A Single-center, Patient- and Assessor-blinded, Randomized Controlled Trial to Compare Patient Outcomes Between Deflated and Inflated Cuff Endotracheal Extubations During Scheduled, Non-airway Surgery in Healthy Adults
Phase: NA
Conditions: Anesthesia Airway Management, Respiratory Complications
Sponsor: Naval Medical Center Camp Lejeune

DEFENSE HEALTH AGENCY
NAVAL MEDICAL CENTER
620 JOHN PAUL JONES CIRCLE
PORTSMOUTH, VIRGINIA 23708-2197
April 28, 2025
MEMORANDUM
From: DHA IRB Office at Naval Medical Center Portsmouth
To:
CDR Michael Lee
Subj: APPROVAL OF NMCCL.2025.0007 “A SINGLE-CENTER, PATIENT- AND ASSESSOR-
BLINDED, RANDOMIZED CONTROLLED TRIAL TO COMPARE PATIENT OUTCOMES 
BETWEEN DEFLATED AND INFLATED CUFF ENDOTRACHEAL EXTUBATIONS 
PROCEEDING SCHEDULED, NON-AIRWAY SURGERY IN HEALTHY ADULTS (DICEE)” 
Ref:
(a) Code of Federal Regulations, Title 32
(b) DoDI 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-
Conducted and -Supported Research”, April 2020, as amended.  
(c) Code of Federal Regulations, Title 45, Part 164 
1. Submission.  A new protocol (EIRB Reference: 975945) was submitted to NMCCL HRPP on 
08/23/2024, completed NMCCL scientific review on10/19/2024, and was submitted to the NMCP IRB on 
10/22/2024.
2. Approval.  Naval Medical Center Portsmouth (NMCP) IRB-2 reviewed NMCCL.2025.0007 “A single-
center, patient- and assessor-blinded, randomized controlled trial to compare patient outcomes between 
Deflated and Inflated Cuff Endotracheal Extubations proceeding scheduled, non-airway surgery in 
healthy adults (DICEE)” and approved on 04/24/2025.  
3. IRB Determinations.  The following determinations were made in accordance with references (a) 
through (c) as part of this approval:
a. Approval Category(ies).  The above referenced study is Full Board.
b. Risk Assessment.  The above referenced study has been assigned a risk rating of Greater than 
Minimal Risk 32 CFR 219 / 21 CFR 56 
c. Enrollment.  The study is approved for 88 subjects. 
d. Study Expiration.  The above referenced study has been approved for a period of one year minus 
one day, with an expiration date of 04/23/2026.  Naval Medical Center Portsmouth IRBs are continuing to 
require continuing reviews for non-exempt human subjects research protocols due to the transient nature 
of base personnel.  
e. Informed Consent.  An informed consent process encompassing all the required elements of 
informed consent IAW 32 CFR 219.116 has been approved.  Investigators must use the stamped IRB-
approved consent form.  Federal regulations require that each subject receive a copy of the consent 
document. 

Subj: Approval of NMCCL.2025.0007 “A single-center, patient- and assessor-blinded, randomized 
controlled trial to compare patient outcomes between Deflated and Inflated Cuff Endotracheal 
Extubations proceeding scheduled, non-airway surgery in healthy adults (DICEE)”
2
f. HIPAA Authorization.  A compound Health Insurance Portability and Accountability Act (HIPAA) 
Authorization has been approved as part of the stamped, IRB-approved consent form.  Federal regulations 
require that each subject receive a copy of the consent document.  
The request for a partial waiver of Health Insurance Portability and Accountability Act (HIPAA) 
Authorization to use or disclose protected health information (PHI) for research screening purposes has 
been approved, in accordance with 45 CFR 164.152, as the use or disclosure of PHI involves no more 
than minimal risk to the privacy of the individuals, 2) the research could not practicably be conducted 
without the waiver or alteration, and 3) the research could not practicably be conducted without access to 
and use of PHI. 
4. Approved Documents.  Approval of the above referenced study includes the following documentation:
Submission Components Approved
Document Type
Version
Date Approved
EIRB Protocol Template
Version 1.5
Perioperative DCT
Version 1.2
04/24/2025
Post-op Symptom Diary
Version 1.1
04/24/2025
Post Op Telephone or in Person Script and DCT
Version 1.2
04/24/2025
Telephone Recruitment Script
Version 1.2
04/24/2025
Subject ID Log
Version 1.0
04/24/2025
Data Spreadsheet
Version 1.0
04/24/2025
Adverse Events log
Version 1.0
04/24/2025
Waiver of HIPAA Authorization for screening purposes only
Version 1.0
04/24/2025
NMCCL.2025.0007 DHA ICF and HIPAA
Version 1.3
04/24/2025
5. Agreements.  It is the Principal Investigator’s (PI’s) responsibility to obtain necessary approvals from 
other offices, such as the DHA Privacy Office, Technology Transfer Office, and/or Information 
Management Control Office, before initiating or continuing research.
6. Protocol Registration.  If indicated in the study protocol, it is the PI’s responsibility to register the study 
with Defense Technical Information Center (DTIC) (https://discover.dtic.mil) and/or 
www.ClinicalTrials.gov as soon as possible.  
7. Post-approval Requirements.  Post-approval study actions must be submitted in EIRB 
(https://eirb.csd.disa.mil) by the PI.
a. Continuing Review.  The study expiration date is 04/23/2026.  The IRB Office strongly 
recommends that continuing reviews are submitted at least sixty days prior to study expiration.  If the 
study expires, the IRB Office will notify study investigators that all study activities must be suspended, 
and the IRB will take steps to administratively close the protocol for non-compliance.  A continuing 
review submission guide can be found on the Clinical Investigation Department (CID) SharePoint 
(https://esportal.med.navy.mil/nmcp/dir/dpe/ci/Pages/EIRB.aspx). 
b. Modifications.  Future modifications (including, but not limited to, changes in study personnel, 
inclusion/exclusion criteria, subject enrollment, or study procedures) must be submitted for IRB review 
and approval prior to implementation.  If scheduled for Temporary Duty (TDY/TAD) of 4 weeks or 
greater, Permanent Change of Station (PCS), or Expiration of Time in Service (ETS), the PI must request 
a change of PI or research study closure and give the research study files to the new NMCP PI or the 

Subj: Approval of NMCCL.2025.0007 “A single-center, patient- and assessor-blinded, randomized 
controlled trial to compare patient outcomes between Deflated and Inflated Cuff Endotracheal 
Extubations proceeding scheduled, non-airway surgery in healthy adults (DICEE)”
3
Department Chief/Head to fulfill research study completion or records retention requirements. A 
modification submission guide can be found on the CID SharePoint 
(https://esportal.med.navy.mil/nmcp/dir/dpe/ci/Pages/EIRB.aspx).
c. Event Reporting.  Any deviation to the protocol that may affect the safety or rights to study subjects 
or the integrity of the study, Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSOs), 
and all Serious Adverse Events (SAEs) must be promptly reported to the IRB and local HRPP via 
telephone (757) 953-5939 or via email (usn.hampton-roads.navhospporsva.list.nmcp-
irboffice@health.mil) within ONE business day of discovery.  A Reportable Event form must be 
submitted within THREE business days of discovery.  An Adverse Event (AE) that is neither serious, nor 
unexpected, nor related to research, should be reported to the IRB and local HRPP at the time of 
continuing review.  If investigators are unsure of the classification of an event, they should contact the 
IRB or local HRPP.  A Reportable Event submission guide can be found on the CID SharePoint 
(https://esportal.med.navy.mil/nmcp/dir/dpe/ci/Pages/EIRB.aspx).
d. Closure.  When the project has been completed, a Closure Report and a manuscript, abstract, or 
summary of study results must be submitted.  If research cannot be completed, a Closure Report must be 
submitted along with an explanation of why the project will not continue.  It is the PI’s responsibility to 
ensure that Closure Reports are uploaded to DTIC (https://discover.dtic.mil) within 90 days of closure.  A 
DTIC submission guide can be found on the CID SharePoint 
https://esportal.med.navy.mil/nmcp/dir/dpe/ci/Pages/IRB Submission Guidance.aspx).  
8. Publication.  All abstracts, presentations, manuscripts, and review articles must be approved by the 
local command prior to submission for publication.  At NMCP, approval request forms may be obtained 
from the CID SharePoint (https://esportal.med.navy.mil/nmcp/dir/dpe/ci/Pages/Publication 
Approval.aspx).  Investigators from other commands should contact their local Public Affairs Office. 
9. Funding.  Approval of this study does not guarantee that funds are available to support it.  If funding 
for supplies, equipment, or personnel is required, contact the NMCP Directorate of Professional 
Education or the PI’s local command. 
10. Contacts.  The local HRPP contact at Naval Medical Center Camp Lejeune is Ms. Chemely Walker 
(chemely.m.walker.civ@health.mil, (910) 450-3460). 
The NMCP IRB Office may be contacted at (757) 953-5939 or via email at usn.hampton-
roads.navhospporsva.list.nmcp-irboffice@health.mil.  SOPs, policies, and guidance can be found on the 
CID SharePoint (https://esportal.med.navy.mil/nmcp/dir/dpe/ci/). 
Signature applied by Kersten N Wheeler  on 04/28/2025 02:22:27 PM CDT
NMCP IRB OFFICE

EIRB Protocol Template (Version 1.5)
1.0
General Information
*Please enter the full title of your protocol:
A single-center, patient- and assessor-blinded, randomized controlled trial to compare patient 
outcomes between Deflated and Inflated Cuff Endotracheal Extubations proceeding scheduled, 
non-airway surgery in healthy adults (DICEE)
 
 
*Please enter the Protocol Number you would like to use to reference the protocol:
DICEE
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol.
 
 
Is this a multi-site protocol (i.e. Each site has their own Principal Investigator)?
No
 
 
Does this protocol involve the use of animals?
Yes
No
 
 
2.0
Add departments
2.1 List sites associated with this study:
Is 
Primary? Site Name
P and R - Naval Medical Center Camp Lejeune (NMCCL)
 
3.0
Assign project personnel access to the project  
3.1 
 Please add a Principal Investigator for the study: 
*
Name
Role
Training Record
Lee, Michael A
Principal 
Investigator
 View Training 
Record
Responsibility
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel: 
A) Additional Investigators 
N

Name
Role
Training Record
HICKS, Leslee Lynne, Speech-
language pathology
Associate Investigator
 View Training Record
Rodriguez, Gabriel A
Associate Investigator
 View Training Record
Schmidt, Rolf
Associate Investigator
 View Training Record
Willett, Peter Bryce
Associate Investigator
 View Training Record
B) Research Support Staff 
Name
Role
Training Record
Adams, Ashley R
Statistician
 View Training Record
Chalas-Reid, Kathiusca Arielis
Research Coordinator
 View Training Record
Kelly, Shannon Yvette, BS Clinical 
Research
Research Coordinator
 View Training Record
3.3 
Please add a Protocol Contact:
*
Name
Role
Training Record
Chalas-Reid, Kathiusca Arielis
Study Contact
 View Training Record
Kelly, Shannon Yvette, BS Clinical 
Research
Study Contact
 View Training Record
Lee, Michael A
Study Contact
 View Training Record
The Protocol Contact(s) will receive all important system notifications along with the Principal Investigator. (i.e. The 
protocol contact(s) are typically either the Protocol Coordinator or the Principal Investigator themselves). 
3.4
If applicable, please select the Designated Site Approval(s):
Name
Role
Training Record
No Designated Department Approval have been added
Add the name of the individual authorized to approve and sign off on this protocol from your Site (e.g. the Site Chair).
4.0
 
Project Information
4.1  
What department(s) will be associated with this protocol?
* 
Anesthesiology

4.2  
Is the IRB of record for this study an IRB/HRPP that does NOT use EIRB? If Yes, complete the 
* 
application according to the IRB/HRPP Determination.
If your Projects or Protocols are under the oversight of another IRB that does use EIRB, stop this 
submission and contact the core site and request an invitation as a performing site.
If your Project or Protocol is now being submitted for the first time to an IRB that does use EIRB, 
continue with this application and answer the questions to be reviewed by the IRB.
Answering yes means the board of record is an IRB that does NOT use EIRB.
  Yes  
  No
4.3  
Is this protocol research, expanded access, or humanitarian use device?
* 
 Yes  
 No
4.4  
 What type of protocol is this?
*
Behavioral Research
Biomedical Research
Clinical trial (FDA regulated)
Educational Research
Expanded Access
Humanitarian Use Device (HUD)
Psychosocial Research
Oral History
Other
4.5  Are you conducting this project in pursuit of a personal degree?
  Yes  
  No
4.7  
Is this human subjects research? (As defined by 32 CFR 219) 
* 
   Human subject means a living 
individual about whom an investigator (whether professional or student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, and 
uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes  
 No
4.8  
 Do you believe this human subjects research is exempt from IRB review?
*
  Yes  
  No
5.0
 
Personnel Details
5.1  Does the Principal Investigator have a Permanent Change of Station (PCS) Date or Estimated 
Institutional Departure Date (EIDD)?
  Yes  
  No

5.2  List any Research Team members without EIRB access that are not previously entered in the protocol:
No results found
5.3  Are any Contractors or Subcontractors involved in this study? If yes, please list them and describe their role.
 Yes  
 No
Name:
(Last, First, M.I.)
Adams, Ashley R
Role on Protocol:
Statistician
Phone Number:
910-449-2862
Email Address:
ashley.r.adams29.
ctr@health.mil
Associated 
Institution:
NMCCL
Name:
(Last, First, M.I.)
Kelly, Shannon Y
Role on Protocol:
Research 
Coordinator
Phone Number:
910-450-3437
Email Address:
shannon.y.kelly.
ctr@health.mil
Associated 
Institution:
NMCCL
Name:
(Last, First, M.I.)
Chalas-Reid, 
Kathy A
Role on Protocol:
Research 
Coordinator
Phone Number:
910-450-5082
Email Address:
kathiusca.a.
chalas-reid.
ctr@health.mil
Associated 
Institution:
NMCCL
5.4  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
Research Monitor Qualifications
Ensure the individual has expertise consistent with the nature of risk(s) identified within your 
study and is independent of the team conducting the research.
Research Monitor Role:

The Data Monitor will be responsible for reviewing severe adverse events that require specialty 
consults, spot checking data entry for accuracy, and confirming that study protocols are being 
followed.
If applicable, you may nominate an individual to serve as the Research Monitor:
Devon Nicole KOVACS
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes  
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
No results found
Total amount of funding:
0
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes  
  No
All personnel engaged in research must complete and attach a Conflict of Interest (COI) form.
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
  Yes  
  No
8.2  Study Facilities and Locations:
Institution Site Name
Site Role
FWA or 
DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB Reviewing 
for Site
Navy
Naval 
Medical 
Center 
Performance 
:
Other
Selected Users

Camp 
Lejeune
site
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing for 
Site
No results found
8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered
  Yes  
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes  
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval)
  Yes  
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Randomized Controlled Trial
Deflated Cuff Extubation
Inflated Cuff Extubation
Airway Contamination
Patient Outcomes
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol.  The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses.  This section establishes 
the relevance of the study and explains the applicability of its findings
The current standard anesthetic practice for extubation is to deflate the endotracheal tube cuff 
using a syringe prior to extubation [1]. While commonplace and nearly universally accepted, this 
practice is not based on evidence from randomized controlled trials [2] but is instead due to 
concern for laryngeal or vocal cord injury and arytenoid cartilage dislocation [3].  However, no 
publications exist in the medical literature that attribute laryngeal trauma directly to inflated cuff 
endotracheal tube extubation, as opposed to the process of extubation in general [4]. To the 
contrary, case reports that describe peri-operative extubation with unintentionally inflated cuffs 
all note the absence of negative outcome [5, 6].

Alternatively, extubation with an inflated endotracheal tube cuff has been advocated as a 
technique to reduce airway complications in human and veterinary medicine [1, 7, 8, 9] . 
Tracheal aspiration, even micro-aspiration by oropharyngeal secretions, may increase the risk of 
pneumonia and other pulmonary complications [10]. Based on an animal model, inflated cuff 
extubation may reduce airway contamination by oropharyngeal fluid [101. Additionally, leaving 
the endotracheal tube cuff inflated may effectively generate a vital capacity breath during 
extubation, maximizing oxygen reserves and facilitating a secretion-clearing cough [12]. These 
theorized advantages may prolong the time to which supplemental oxygen is required as well as 
decrease airway/respiratory complications in the immediate post-extubation period.
Within the intensive care setting, unplanned extubation (including accidental extubation and self-
extubation) occurs at a rate of 3% to 16% of intubated patients or 0.1 to 3.6 per 100 days of 
mechanical ventilation [13, 14, 15, 16]. Estimates of national hospitalizations requiring 
mechanical ventilation approach 800,000, thereby placing the estimated number of unplanned 
extubations between 24,000 and 128,000 [17]. Presumably, the majority of these unplanned 
extubations are with inflated cuffs, and yet still no epidemic of laryngeal trauma from inflated 
cuff extubation exists. Furthermore, there have been no significant differences in laryngeal 
complications reported between planned and unplanned extubation in the intensive care 
population, suggesting that it is the endotracheal tube itself (and the process of placing it) that 
confers the risk of laryngeal complications, rather than the circumstances of its removal [18, 19].
Though several providers have published their success with inflated cuff extubation, to date no 
prospective, randomized controlled trial has been performed directly comparing these two 
techniques. We propose to study the effect of inflated cuff extubation on airway contamination 
by oropharyngeal material, extubation quality, post-extubation oxygenation, and laryngeal 
symptoms compared to the standard technique of deflated cuff extubation.
To assess the difference in aspiration rates between deflated and inflated cuff extubation, we 
propose to use radio-opaque contrast material introduced into the oropharynx of intubated 
patients while under general anesthesia.  Two prior studies have instilled contrast media into the 
oropharynx of intubated patients while under general anesthesia to evaluate incidence and 
severity of pulmonary contamination [20, 21], demonstrating aspiration in 75% and 20% of 
patients, respectively.  These studies compared different methodologies of removing gastric 
contents and oropharyngeal contents.  The aspiration rates of conventional secretion-clearing 
techniques in these studies were 100% and 30%, respectively.  A study evaluating continuous 
suction of subglottic secretions demonstrated a lower-airway contamination rate of 56% in the 
control group that reflected conventional practice [22].  Although this study used fiberoptic 
bronchoscopy and methylene blue, we hold that its protocol most accurately resembles modern 
technique and equipment, as well as the aims of our study.  Of note, a related study used 15 ml 
of barium sulfate introduced into the oropharynx of patients under general anesthesia to 
demonstrate the protection from aspiration conferred by an endotracheal tube or laryngeal mask 
airway [23].  However, no post-extubation films were taken.  These authors did opine that 
radiographic exams for aspirated contrast material would be more sensitive that fiberoptic 
examination for methylene blue.  
Careful consideration went into selecting our contrast agent, as the medium needed to be 
adequately sensitive to detect aspiration on plain film x-ray and, importantly, to present 
minimum risk to research subjects.  Barium sulfate is a widely used contrast agent often used for 
swallow studies in which aspiration is possible.  While some patient may tolerate low volume 
barium aspiration without symptoms, severe respiratory distress and even mortality has been 
reported [24].  In patients at risk for aspiration, low-osmolar water-soluble contrast agents such 
as iohexol (omnipaque) have been advocated as safer alternatives that barium and high-osmolar 
water-soluble contrasts agents [25, 26, 27, 28]. Two large studies encompassing a total of 2,733 
exams compared iohexol to barium to assess its suitability for swallow study [29, 30].  Harris et 
al identified 36 aspiration events with iohexol, noting that 4-5 ml of iohexol (omnipaque 350) 
was initially given “when aspiration was of concern” and that the amount of aspirated iohexol 
was “usually less than 1ml.”  Harris et al also stated that the only subjects who experienced mild 
symptoms of pulmonary edema were three patients with fistulous connections to the 
airway.  Only one patient, again a patient with an esophageal-airway fistula, experienced 
respiratory symptoms in the form of brief stridor.  Hwang et al observed 147 aspiration events 
with iohexol (omnipaque 350) with a mean aspirated volume of 6.7 ml.  Most relevant to our 
proposed study, Hwang et al concluded that WSCA (iohexol)-based swallowing study “was 
significantly better at detecting aspiration than MBSS (modified barium swallowing study)” and 
that “aspirated WSCS (water-soluble contrast solution) was not accompanied by significant 
pulmonary edema, whereas chemical pneumonitis resulted from aspirated barium.  
The safety profile of intrapulmonary iohexol can also be supported by its use in 
tracheobronchography.  Tracheobronchography is a radiologic technique in which a contrast 
agent is intentionally placed into the airway and then visualized by plain film x-rays, allowing 
examination of the tracheal and bronchial anatomy.  Iohexol has been used for 

tracheobronchography for neonatal, pediatric, and adult patients [31, 32, 33, 34], under general 
endotracheal anesthesia and sedation.  Some pediatric patients were critically ill and ventilator
/oxygen dependent at the time of the examination.  In the case series of four adults undergoing 
tracheobronchography, 20-30 ml of iohexol was injected into the tracheobronchial tree.  These 
case series all emphasize that no deteriorations in respiratory status were observed.  One 
accidental bronchography was obtained during the conduct of an iohexol-based swallow study in 
which 10 ml of iohexol was aspirated [35].  That patient experienced no respiratory distress and 
required no supplemental oxygen administration.
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
The objective of this study is to compare patient outcomes between endotracheal 
tube inflated cuff extubation (ICE) and the conventional practice of deflated cuff 
extubation (DCE).
AIM 1: Airway Contamination
To determine the difference of lower airway contamination by pharyngeal fluid 
between ICE and DCE, as measured by the propagation of contrast material to or 
below the level of the carina, assessed by plain film radiographs.
AIM 2: Respiratory Complications
To determine the extubation quality difference between ICE and DCE, as 
measured by complications of coughing, hypoxemia, airway obstruction, 
bronchospasm, stridor, laryngospasm, and aspiration.
AIM 3: Supplemental Oxygen
To determine the difference in post-extubation oxygenation between ICE and 
DCE, as measured by the need for and time to supplemental oxygen 
administration.
AIM 4: Laryngeal Complications
To determine the relative risk of laryngeal complications between ICE and DCE, 
as measured by symptoms of hoarseness, dysphonia, sore throat, cough, and 
dysphagia 24 to 48 hours postoperatively.
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug 
research
This is a single-center, patient- and assessor-blinded, parallel arm, prospective, interventional, 
randomized controlled trial.
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Healthy adult patients undergoing scheduled, non-airway surgeries

9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
This study will be the first to evaluate the inflated cuff extubation technique. It has published 
support by practicing anesthesiologists and potential advantages supported by an animal model 
study. Refinement of peri-operative extubation practices may result in fewer airway or 
respiratory complications, improving patient safety and experience.
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
Standard of Care Intubation and Airway Management (ALL PATIENTS)
All patients will be intubated using standard of care procedures at NMCCL.
Induction of anesthesia will involve the use of neuromuscular blocking agents to facilitate 
laryngoscopy. Otherwise, induction of anesthesia will be at the discretion of the PI. 
Oropharyngeal and/or nasopharyngeal airways will be placed only if deemed necessary to 
adequately mask ventilate. Intubation will be performed by the PI via direct laryngoscopy only. 
Biologic males will be intubated with a 7.5mm internal diameter 10.2 outer diameter Sheridan 
/HVT endotracheal tube, product reference number 5-10315, with the cuff placed approximately 
3-4 cm distal to the vocal cords. Biologic females will be intubated with a 7.0mm internal 
diameter, 9.6mm external diameter Sheridan/HVT endotracheal tube, product reference number 
5-10314, with the cuff placed approximately 3-4 cm distal to the vocal cord.  No local anesthetics 
will be topically applied to the airway or the endotracheal tube. Following endotracheal 
intubation, the endotracheal tube will be secured with adhesive tape and the cuff pressure will be 
confirmed to be in the range of 25-30 cm H2O.
All patients will receive dexamethasone 0.2mg/kg IV within thirty minutes of intubation. No 
nitrous oxide will be administered. Patients will otherwise be administered an anesthetic 
maintenance plan deemed most suitable based on their clinical circumstances and the surgical 
intervention, per the judgment of the PI. Use of orogastric tube will be noted. Ventilation will be 
performed with tidal volumes 5-7 ml/kg ideal body weight, fractional inspiratory concentration of 
oxygen between 21-50%, positive end-expiratory pressure 5-15 cm H2O, and a respiratory rate 
titrated to an end-tidal carbon dioxide concentration of 35-40 mmHg.
Extubation (ALL PATIENTS)
Approximately 20 minutes prior to end-of-surgery, a nasal cannula with end-tidal carbon dioxide 
sampling capability will be appropriately positioned on the patient. The endotracheal tube cuff 
pressure will be re-checked to confirm it is within a range of 25-30 cm H2O. Any indwelling 
gastric tube will be removed without applying suction to the oropharynx. The patient will be 
returned to a leveled position.
To identify the presence of airway contamination in the post-operative x-ray, 20 ml of the 
contrast material iohexol 350 (Omnipaque) will be instilled into the oropharynx via syringe. This 
procedure is for research purposes only and is not standard of care.  A soft bite block will be 
placed. At end-of-surgery, the fractional inspiratory concentration of oxygen will be increased to 
100% with fresh gas flow at 10 liters/min. Oropharyngeal contents will be removed blindly with a 
rigid Yankauer suction catheter. Sugammadex 2-4mg/kg for reversal of neuromuscular blockade 
will be administered. A regular breathing pattern and adequate spontaneous ventilation will be 
established. Continuous positive airway pressure will be set to 10 cm H2O.
Allocation (ALL PATIENTS)
The PI will then open the sealed envelope corresponding to the patient’s Study ID to reveal the 
patient’s group allocation. On eye-opening and/or purposeful spontaneous movement, the 
principal investigator will then perform either Deflated Cuff Extubation (DCE) or Inflated Cuff 
Extubation (ICE) as assigned. An Anesthesiologist AI will be present in the OR to collect research 
data but will be blinded to the patient’s allocation.
Arm 1 – Deflated Cuff Extubation
The adjustable pressure-limiting (APL) valve will be set to 20 cm H2O. All air will be removed 
from the endotracheal tube cuff pilot balloon with a 10ml syringe. The endotracheal tube will be 
withdrawn into an opaque blue towel, to prevent the Anesthesiologist AI from identifying the 

patient’s allocation, while the reservoir bag is simultaneously compressed to generate at least 20 
cm H2O positive airway pressure.
Arm 2 – Inflated Cuff Extubation
The APL valve will be set to 20 cm H2O. To blind the Anesthesiologist AI from the patient’s group 
allocation, sham deflation of the endotracheal tube cuff pilot balloon will be performed with a 
10ml syringe. The endotracheal tube will be withdrawn into an opaque blue towel while the 
reservoir bag is simultaneously compressed to generate at least 20 cm H2O positive airway 
pressure. In the rare event significant resistance is met with attempted extubation, the principal 
investigator will deflate the cuff in one milliliter increments until extubation is possible. This 
process does not unblind the Anesthesiologist AI.
Post-Extubation (ALL PATIENTS)
The PI will confirm positive end-expiratory carbon dioxide via the anesthesia mask and circuit. 
Once airway patency is confirmed, supplemental oxygen will be withdrawn. Ventilation will be 
monitored by nasal cannula end-tidal carbon dioxide sampling.
When supplemental oxygen is withdrawn, the Anesthesiologist AI will then begin a six-minute 
timer, during which time any airway complications, further supplemental oxygenation via the 
nasal cannula (as determined by if the patient’s arterial oxygenation reaches 94% or lower by 
pulse oximetry), or other interventions performed will be recorded, along with the time elapsed, 
in the medical record and on the research data collection tool (DCT).
As is standard, following the observation period the patient will be transferred to the Post-
Anesthesia Care Unit (PACU) in the semi-upright position if medically able.  
To answer the primary research question of airway contamination, the patient will receive a 
portable anteroposterior chest x-ray in the semi-upright position in Phase 1 recovery. The x-ray 
order will be placed by the PI. If a delay occurs, the chest x-ray can be taken in Phase 2 
recovery. If the portable chest x-ray is not available, the chest x-ray will be obtained in the 
radiology department.
An investigator will confirm the patient’s ability to phonate before discharge from Phase 1 
recovery. Otolaryngology will be urgently consulted in the event the patient does not recover 
ability to phonate or if symptoms consistent with critical upper airway obstruction develop, as is 
the NMCCL policy.
After the patient has been discharged from the PACU, the Anesthesiologist AI will collect 
demographic and comorbidity data from the patient chart to add to the research DCT.  The 
patient will receive a one-page symptom diary on which to record answers regarding their 
potential laryngeal complications for the first 24 hours, to aid them in recalling their symptom 
details for the post-op phone call.
Post-Operative Day 1-2 (ALL PATIENTS)
24 to 48 hours postoperatively, the SLP AI will contact the patient. Most participants are 
expected to have already been discharged at this point. For these participants, the SLP AI will 
contact them by phone, using the postoperative telephone script. For participants still in the 
hospital, the SLP AI will visit the participant’s patient room. The SLP AI will assess for the 
following: sore throat presence/severity, cough symptom score, voice quality (as measured by 
Grade, Roughness, Breathiness, Asthenia and Strain, also known as the GRBAS scale), and 
dysphagia presence/severity. This data will be recorded on a research DCT. Patients will be then 
informed that their participation in the research study is complete.
If the SLP AI is not available, this phone call or room visit will be made by a member of the study 
staff who is not the PI and the data will be provided to the SLP AI. Further evaluation for 
laryngeal dysfunction will be at the professional judgment of the SLP AI. Any evaluation beyond 
the data collected in the phone call will not be included in the research data.
Three attempts will be made by study staff to contact the patient via telephone. Participants who 
are not able to be contacted by phone will be considered lost to follow up.
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured.
Primary Outcome: Airway Contamination
Airway contamination will be measured by the presence of contrast in the airway following the 
extubation. After the endotracheal tube has been inflated, but prior to extubation, 10 ml of the 
contrast material iohexol will be instilled into the patient's oropharynx. This contrast material will 
serve as a radio-opaque marker to assess on plain film x-rays whether oropharyngeal secretions 
have entered the airway.

To detect the presence of contrast in the airway, an anterior-posterior (AP) chest x-ray will be 
taken in the PACU. The presence of contrast at or below the level of the carina will be assessed 
by a hospital staff radiologist and will be reported as a yes or no event.
Secondary Outcome: Laryngeal Complications
Phonation (PACU)
After admission to the PACU but prior to PACU discharge, the patient’s ability to phonate will be 
assessed by an AI and recorded as a yes or no event.
Sore Throat (Postoperative)
24 to 48 hours postoperatively, the patient will be contacted by the SLP AI (or secondarily by an 
anesthesiologist AI) to assess sore throat. Patients will be asked to rate their sore throat over 
the first 24 hours postoperatively on the following 4-point Likert scale:
Score
Description
0
No sore throat at any time since the operation
1
Minimal sore throat
2
Moderate sore throat
3
Severe sore throat
Sore throat will be reported both as a yes or no event and also by severity level.
Cough (Postoperative)
24 to 48 hours postoperatively, the patient will be contacted by the SLP AI (or secondarily by an 
anesthesiologist AI) to assess cough. Patients will be asked to rate their cough over the first 24 
hours postoperatively using the Simplified Cough Score (SCS) [36, 37] for both the daytime and 
nighttime.
Voice Quality (Postoperative)
24 to 48 hours postoperatively, the patient will be contacted by the SLP AI (or secondarily by an 
anesthesiologist AI) to assess their voice quality. The AI will rate the patient’s voice quality using 
the Grade, Roughness, Breathiness, Aesthenia and Strain (GRBAS) scale [38, 39].
Dysphagia (Postoperative)
24 to 48 hours postoperatively, the patient will be contacted by the SLP AI (or secondarily by an 
anesthesiologist AI) to assess dysphagia. Patients will be asked to rate their difficulty swallowing 
over the first 24 hours postoperatively using the Bazaz Dysphagia Score (BDS). [40]
Secondary Outcome: Respiratory Complications
Post-extubation respiratory complications include coughing, hypoxemia, airway obstruction, 
bronchospasm, stridor, laryngospasm, and aspiration. These complications will be measured for 
six minutes following the confirmation of airway patency and withdrawal of supplemental oxygen.
Cough
Post-extubation cough severity will be determined by the Modified Minogue Scale, or MMS [41, 
42]. The most severe grade that occurs during the six-minute window will be recorded on the 
DCT.
Hypoxemia
Hypoxemia will be measured by any pulse oximetry reading with an appropriate 
plethysmographic waveform. It will be reported both as a yes or no event and also by severity 
level during the six-minute window. Hypoxemia levels will be defined as follows:
Hypoxemia Level
Description
None
Spo  ≥ 95%
2
Mild
Spo  91% - 94%
2
Moderate
Spo  86% - 90%
2
Severe
Spo  80% - 85%
2
Critical
Spo  ≤ 79%
2
The most severe level that occurs during the six-minute window will be recorded on the DCT.
Obstruction

Obstruction will be defined as the narrowing or occlusion of the airway by supraglottic anatomical 
structures resulting in impaired ventilation and will be recorded as a yes or no event during the 
six-minute window.
Stridor
Stridor will be defined as an abnormal, high-pitched respiratory sound produced by irregular 
airflow in a narrowed airway and will be recorded as a yes or no event during the six-minute 
window.
Laryngospasm
Laryngospasm will be defined as partial or complete airway structure due to maladaptive reflect 
closure of the vocal cords and will be recorded as a yes or no event during the six-minute 
window.
Aspiration
Aspiration will be defined as respiratory distress due to inhaled gastric contents as established by 
witnessed event, radiologic study, or bronchoscopy. It will be recorded as a yes or no event 
during the six-minute window.
Bronchospasm
Bronchospasm will be defined as deleterious spasmodic bronchial smooth muscle contraction and 
will be recorded as a yes or no event during the six-minute window.
Secondary Outcome: Supplemental Oxygen
Should a patient’s arterial oxygenation reach 94% or lower after extubation, the patient will be 
supplied with supplemental oxygen. If this occurs, the need for supplemental oxygen will be 
recorded as a yes or no event, as will the time in minutes at which this event occurs.
List of Variables:
Variable
Timing
Measurement
Type
Age
DOS Pre-
Op
Years
Numeri
c
Biological Sex
DOS Pre-
Op
M/F
Catego
rical
Weight
DOS Pre-
Op
kg
Numeri
c
Height
DOS Pre-
Op
cm
Numeri
c
ASA Status
DOS Pre-
Op
1,2,3
Ordinal
GERD
DOS Pre-
Op
Y/N
Catego
rical
Asthma
DOS Pre-
Op
Y/N
Catego
rical
Smoking
DOS Pre-
Op
Y/N
Catego
rical
Other Significant 
Comorbidities
DOS Pre-
Op
Text
Catego
rical
Pre-Operative SpO2
DOS Pre-
Op
%
Numeri
c
Pre-Operative Voice 
Quality
DOS Pre-
Op
Grade, Roughness, 
Breathiness, Aesthenia 
and Strain (GRBAS) scale
Ordinal
Date Of Surgery
DOS Pre-
Op
DDMMMYYYY
Date
/Time
Indication Of Surgery
DOS Pre-
Op
Text
Catego
rical

Start Of Surgery Time
DOS 
Intubation
2400 Format
Date
/Time
Time Of Intubation
DOS 
Intubation
2400 Format
Date
/Time
Completed Procedure
DOS 
Intubation
Y/N
Catego
rical
End Of Surgery Time
DOS 
Intubation
2400 Format
Date
/Time
Maintenance 
Medications
DOS 
Intubation
Text
Catego
rical
Emergence Medications
DOS 
Intubation
Text
Catego
rical
Contrast Instillation 
Time
Extubation Time
DOS 
Extubation
DOS 
Extubation
2400 Format
2400 Format
Date
/Time
Date
/Time
Out Of Room Time
DOS 
Extubation
2400 Format
Date
/Time
SpO  At Extubation
2
DOS 
Extubation
%
Numeri
c
Cough
DOS 
Extubation
Modified Minogue Scale
Ordinal
Laryngospasm
DOS 
Extubation
Y/N
Catego
rical
Obstruction
DOS 
Extubation
Y/N
Catego
rical
Bronchospasm
DOS 
Extubation
Y/N
Catego
rical
Stridor
DOS 
Extubation
Y/N
Catego
rical
Additional Suctioning
DOS 
Extubation
Y/N
Catego
rical
Chin Lift
DOS 
Extubation
Y/N
Catego
rical
Positive Pressure
DOS 
Extubation
Y/N
Catego
rical
2-Hand Jaw Thrust
DOS 
Extubation
Y/N
Catego
rical
Oral Airway
DOS 
Extubation
Y/N
Catego
rical
Medications Needed
DOS 
Extubation
Y/N
Catego
rical
Type of Medication 
Used
DOS 
Extubation
Text
Catego
rical
Time To Supplemental 
Oxygen
DOS 
Extubation
Seconds
Numeri
c
Oxygen Source
DOS 
Extubation
Room Air, Nasal Cannula, 
Simple Face Mask, 
Anesthesia Circuit
Catego
rical
O  Flow
2
DOS 
Extubation
L/min
Numeri
cal
SpO  At 6Mins Post-
2
Extubation
DOS 
Extubation
%
Numeri
cal
PACU Arrival Time
DOS 
PACU
2400 Format
Date
/Time
Ability To Phonate 
Y/N

DOS 
PACU
Catego
rical
Airway/Respiratory 
Complications
DOS 
PACU
Y/N
Catego
rical
Description of 
Complication
DOS 
PACU
Text
Catego
rical
Presence of Contrast 
on X-Ray
DOS 
PACU
Y/N
Catego
rical
PACU Discharge Time
DOS 
PACU
2400 Format
Date
/Time
Sore Throat
24 hours 
postoperat
ive
4-pt Likert Scale, 0-3
Ordinal
Cough
24 hours 
postoperat
ive
Simplified Cough Score
Ordinal
Voice Quality
Postoperat
ive
24 hours 
postoperat
ive
Grade, Roughness, 
Breathiness, Aesthenia 
and Strain (GRBAS) scale
Ordinal
Dysphagia
24 hours 
postoperat
ive
Bazaz Dysphagia Score
Ordinal
Symptom Assessment Scales
Modified Minogue Scale (MMS)
Post-extubation cough severity will be determined by the Modified Minogue 
Scale, or MMS. The MMS is a 5-point scale, where a patient’s cough is graded 
from 1 to 5. [41, 42] Higher grades are associated with more severe coughing, as 
seen below. The MMS is an assessment of coughing after emergence from 
general anesthesia and modifies 3-point and 4-point cough scales that had been 
used previously, [41, 42] having been adjusted to improve validity of the scale. 
There is currently no reliability data from this scale.
Grade
Description
1
No coughing or muscular stiffness
2
Transient cough response to the removal of the tracheal tube that 
resolves after extubation
3
Moderate coughing (# 3 coughs, each lasting for 1-2 seconds
4
Severe cough or muscular stiffness (# 4 coughs, each lasting > 2 
seconds)
5
Severe restlessness and associated laryngospasm
Simplified Cough Scale (SCS)
The SCS will be used to assess cough severity postoperatively. The SCS is a 2-
item score for daytime and nighttime severity, rated on a 4-point scale from 0 to 
3, in which a higher score indicates increased severity, as shown below. Internal 
consistency of the SCS is acceptable, with a Cronbach’s # between 0.74 to 0.90. 
Additionally, the SCS’s repeatability is high, with an interclass correlation 
coefficient of 0.76. [37]
Sc
or
e
Daytime Description
Nighttime Description
0
No cough
No cough

1
Occasional transient 
cough during the day
Occasional transient cough before sleep or during the 
night
2
Frequent cough 
mildly affecting daily 
life
Cough mildly affecting night sleep
3
Frequent cough 
severely affecting 
daily life
Cough severely affecting night sleep
Grade, Roughness, Breathiness, Aesthenia, Strain (GRBAS) Scale
The GRBAS scale will be used to assess voice quality pre- and postoperatively. 
On the GRBAS scale, each item on the scale is scored from 0 to 3, where 0 is 
normal voice quality for that item, and 3 is severely abnormal. Definitions for the 
voice qualities measured by GRBAS are as follows:
Compon
ent
Description
Grade
Degree of hoarseness of the voice
Roughne
ss
Impression of irregularity of the vibration of the vocal folds
Breathin
ess
Degree to which air escaping from between the vocal folds can be 
heard by the examiner
Asthenia
Degree of the weakness heard in the voice
Strain
Extent to which strain or hyperfunctional use of phonation is heard
Test-retest reliability, intra-rater reliability and inter-rater reliability of the GRBAS 
scale are satisfactory. Test-retest reliability coefficients range from .75 to .83, 
intra-rater reliability coefficients range from .69 to .81, and inter-rater reliability 
coefficients range from .69 to .78, with an exception for Strain, which has a lower 
inter-rater reliability of .48. [43, 44]
Bazaz Dysphagia Score (BDS)
The BDS will be used to assess postoperative dysphagia. The BDS is a 4-point 
Likert scale from 0 to 3, with a larger score indicating a higher severity of 
dysphagia. Though no formal validity or reliability data have been established, the 
BDS is both the first and most popular patient-reported objective measure of 
dysphagia. [40, 45]
Score
Grade
Description
0
None
No episodes of difficulty swallowing
1
Mild
Only rare episodes of difficulty swallowing
2
Moderate
Occasional swallowing difficulty with solid foods
3
Severe
Swallowing difficulty with solids and liquids
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
 Yes  
 No
10.4  Review the definitions below and respond to the following two questions.  If you are not sure of the 
answers, email 
 for assistance.
DHA.PrivacyBoard@mail.mil
   The 
 is 
Military Health System (MHS)
defined as all DoD health plans and DoD health care providers that are organized under the 
management authority of, or in the case of covered individual providers, assigned to or employed by, 
  
the Defense Health Agency (DHA), the Army, the Navy, or the Air Force  
 
MHS workforce members
are employees, volunteers, trainees, and other persons whose conduct, in the performance of work 
  
for the MHS, is under the direct control of the MHS, whether or not they are paid by the MHS.  MHS 
 are persons or entities that provide a service to the MHS and require protected 
business associates
health information (PHI) to provide the service.

Are you an MHS workforce member?
Yes, I am an MHS workforce member 
No, I am not an MHS workforce member 
10.5  Have you consulted with an MHS data expert to determine the data elements required for your study?
Consulting with a data expert often saves time later in the compliance process because the data 
expert can advise on the data available in the numerous MHS information systems, the quality of 
that data and the methods for encrypting and collapsing data.  To schedule a consult with an 
MHS data expert, send an email to: (
)
DHA.PrivacyBoard@mail.mil
Yes, then complete the questions below according to the data consult 
No, then complete the questions below according to the best of your knowledge 
10.6  Indicate how you will request data from the MHS.  Select all that apply.
Talking with MHS health care providers or MHS health plans about specific research 
participants
Obtaining MHS hard copy records specific to research participants
Obtaining data from an MHS information system(s)
10.7  If you are obtaining data from an MHS information system(s), indicate whether you plan to receive a 
data extract or whether you plan to access an MHS information system directly to create a data set.
A data extract is when the MHS or a contractor provides the data set directly to the 
researcher.  When receiving a data set through data extract, the researcher may indicate 
whether the data elements should be provided as is, encrypted or collapsed.  In contrast to a 
data extract, access to an information system means that the researcher may directly access an 
MHS information system and create a data set for the research study
Data Extract
Access
10.8  Do you intend to request de-identified data from the MHS in your research study? 
There are different two methods for de-identifying data pursuant to HIPAA:
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the 
researcher does not have actual knowledge that the remaining data can be used alone or in 
combination with other information to identify the individual who is the subject of the information
2) Statistical Method: An expert, with appropriate knowledge of and experience with generally 
accepted statistical and scientific principles and methods for rendering information not 
individually identifiable, determines that the data is not individually identifiable
  Yes  
  No
10.9  Indicate the MHS information system(s) from which you will seek to obtain data
If you do not know which system(s) contains the data elements you need, refer to the Guide for 
DoD Researchers on Using MHS Data or request guidance from an MHS data expert at: DHA.
.
PrivacyBoard@mail.mil
 
Below is a list of commonly used MHS systems. If the system from which you seek to obtain 
data is not listed below, list the name of the system in the “Other MHS Systems” category below
PHI Systems:
MHS Information System
Requesting Data
:
MHS Genesis
:
No

PII-Only Systems:
MHS Information System
Requesting Data
No results found
De-Identified Data & Other Systems:
Information System
Requesting Data
No results found
10.10  Do you intend to merge or otherwise associate the requested data with data from any sources 
outside of the MHS, including other DoD systems that are not part of the MHS?
Yes, will merge data 
No, will not merge data 
10.11  Indicate the data elements about research participants or relatives, employers, or household 
members of the research participants that you will request from MHS hard copies or from MHS 
information systems. 
If you will merge data, also indicate non-MHS data elements about research participants or 
relatives, employers, or household members of the research participants that you will have access 
to in any form or medium.
Direct and 
Indirect 
Identifiable Data 
Elements
DHA Hard 
Copies
DHA Data 
Elements 
to be 
Accessed
DHA Data 
Elements 
Verbal
Extracted 
DHA 
Digital 
Data
Downloaded 
DHA Digital 
Data
Non-DHA 
Hard 
Copies or 
Digital
1.  Names 
2.  Postal 
address with 
only town, 
city, state, 
and zip code 
3.  Postal 
address with 
all geographic 
subdivisions 
smaller than 
state, 
including 
street 
address, city, 
county, 
precinct, zip 
code and their 
equivalent 
geocodes, 
except for the 
initial three 
digits of a zip 
code if, 
according to 
the current 
publicly 
available data 

from the 
Bureau of 
Census: 1) 
the 
geographic 
unit formed by 
combining all 
zip codes with 
the same 
three initial 
digits contains 
more than 
20,000 
people; and 2) 
the initial 
three digits of 
a zip code 
from all such 
geographic 
units 
containing 
20,000 or 
fewer people 
is changed to 
000
4.  Dates 
including all 
elements 
(except year) 
directly 
related to an 
individual, 
including 
birthdate, 
admission 
date, 
discharge 
date, and date 
of death 
5.  Ages over 
89 and all 
elements of 
dates 
(including 
year) 
indicative of 
such age, 
unless you will 
only request a 
single 
category of 
“age 90 or 
older” 
6. Telephone 
Numbers
7.  Fax 
Numbers 

8.  Email 
Addresses
9.    Social 
Security 
Numbers
10.   Medical 
Record 
Numbers 
(MRN) 
(including 
record ID)
11.   Health 
Plan 
Beneficiary 
Numbers  
(including 
DEERS ID, 
Electronic 
Data 
Interchange 
Personal 
Identifier 
(EDIPI) or 
Number 
(EDIPN))
12.   Account 
Numbers 
13.   Certificate
/License 
Numbers 
14.   Vehicle 
identifiers and 
serial 
numbers, 
including 
license plate 
numbers 
15.   Device 
identifiers and 
serial numbers 
16.   Web 
Universal 
Resource 
Locators 
(URLs) 

17.   Internet 
Protocol (IP) 
address 
numbers 
18.   Biometric 
identifiers, 
including 
finger and 
voice prints 
19.   Full-face 
photographic 
images and 
any 
comparable 
images
20.   Any 
other unique 
identifying 
number, 
characteristic, 
or code 
(including non-
military 
provider IDs)
21.   Free Text 
Fields
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot 
be used.
Due to guidelines stated within DoDI 1000.30, Reduction of SSN Use within DoD, the reduction 
or elimination of SSN usage must occur wherever possible. If SSNs are required to complete the 
project, the PI must provide a justification and explanation as to why a substitution cannot be 
used.
For example:
• If alternatives to SSN (e.g., EDIPNs or pseudo person IDs) are sufficient in other instances, 
will those alternatives to SSN usage be sufficient to respond to Congressional inquiries and
/or Senior DoD stakeholders inquiries?
• Are alternatives to SSN used first?
• Are those alternatives to SSN insufficient to combine data from multiple data sources? Is 
the issue that some individuals do not possess alternatives ID numbers and SSN is the only 
way to identify them?
No SSNs will be obtained.
a. Will you receive or obtain health information?
Note: If you indicate you are not receiving health information, the answer 
must be consistent with the DHA data source. For a non-health 
information data request, if you are a non-MHS employee or non-MHS 
business associate, you may not access an information system that has 
PHI or LDS. For both MHS and Non-MHS employees and MHS business 
associates, you may 
 include data elements in the above table on: 
NOT

1)  lines 10 or 11, 2) line 21 if the free text field comes from a PHI or LDS 
system, and 3) lines 12, 13, or 18 if the account numbers, certificate and 
license numbers, biometric data, or any other data elements are health 
information created or received by an MHS health care provider, health 
plan, or business associate in relation to the physical or mental health or 
condition of an individual or payment for health care.
Yes, I will receive or obtain health information 
No, I will not receive or obtain health information 
b. If no data elements were checked in the above table, is it possible that the requested DHA 
data is or will be identifiable because of any unique data elements, triangulation, or small cell 
size?  
Data elements were checked in the above table, STOP HERE.
NOTE: A unique data element includes any unique features that alone are not identifiable but 
that could be used to identify an individual within the context of other information, such as any 
type of code (such as diagnosis or procedural), rank of general or admiral, gender, or race. 
Triangulation means using different data elements that when combined can be used to identify 
an individual, such as including the above lists of unique data elements in a data set. 
Determining whether an individual is identifiable through triangulation requires consideration of 
all data elements in combination. Within the military, the use of rank and/or diagnosis code, 
procedural codes, or any other code that changes on a predictable basis, increases the possibility 
of identification. Small cell size means that there is only a small number of eligible individuals 
that satisfy the category description. Department of Defense Manual 6025.13, Medical Quality 
Assurance and Clinical Quality Management in the Military Health System MHS, provides that the 
threshold for de-identifying data within the MHS requires a cell size of three, but also states that 
the de-identification standards must meet the DoD implementation of the HIPAA Privacy Rule. 
Centers for Medicare and Medicaid also gives guidance on small cell size stating that no data cell 
less than 11 may be published or displayed. However, the Office for Civil Rights’ OCR, which is 
the official regulatory office for the HIPAA Privacy Rule, provides that OCR does not designate a 
universal value for small cell size in accordance with the de-identification standard; instead, the 
cell size should be set at a level that is appropriate to mitigate risk of identification by the 
anticipated recipient of the data set. This means that a cell size of 3 or 11 may not meet the 
HIPAA Privacy Rule requirements if the cell size level does not appropriately mitigate risk of 
identification by the anticipated recipient of the data set.
Note: If dates are altered as a means of de-identifying the data, diagnosis and 
procedural codes need to be rolled-up or collapsed. If dates are provided “as time 
between events,” the roll-up is not necessary.   
Yes, the DHA data will become identifiable
No, the DHA data will not become identifiable
10.12  Do you believe it is possible for the MHS data to become identifiable because of triangulation, a 
small cell size, or any unique data element(s)?
Triangulation means using different data elements that are not themselves identifiable but that 
when combined can be used to identify an individual. For example, triangulation would use rank 
and race together to determine the identity of an individual with a particular health condition.
 
Small cell size means that there is only a small number of eligible individuals that satisfy the 
category description. Guidance for acceptable cell size is available from the Centers for Medicare 
and Medicaid Services. For example, the rank category of four star generals with a particular 
diagnosis may be less than 30, so the rank category may need to be expanded to include lower 
ranks.
 
A unique data element includes any unique features that are not explicitly enumerated in the 
categories of data in rows 1 – 20 of the table above (in Section 10.10), but that could be used to 
identify an individual. Unique data elements include characteristics that are not themselves 
identifying, such as the rank of general or admiral, or a race or gender, but within the context of 
other information could be identifiable.
Yes, I believe there is a reasonable possibility the MHS data will become identifiable 
No, I believe there is no reasonable possibility the MHS data will become identifiable 

10.13  Have you completed and uploaded an appropriate HIPAA document ( i.e. HIPAA Authorization will 
be obtained or Waiver/alteration of HIPAA Authorization is being requested)?
Yes 
No 
N/A 
If yes, please check which one.
HIPAA Authorization
HIPAA Waiver (Full or Partial)
Other (please provide copies when uploading Other Study Documents)
10.14  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during 
the study, data/specimen storage and length of time stored, shipment/transmission, and the 
plan for storage and final disposition at the conclusion of the study. Describe any data 
agreements in place for accessing data within and/or outside of your institution (e.g., Data 
Sharing Agreement, Data Use Agreement, Business Agreements, etc.)
Data will be collected through patient interaction and inquiry into the MHS records. This 
information will be recorded on hard copy Data Collection Tools (DCTs), which will only be 
identified via the Study ID number. The DCT hard copies will be kept in a locked document safes 
in the Anesthesia workroom or Speech Language Pathologist’s office.
A master list will be created to connect PII/PHI with the study identifier. This electronic file will 
be maintained by the PI, who is the only unblinded member of the study staff, in a file location 
that is separate from research data labeled with patient Study IDs. The master list will be 
password protected, and saved onto a secure, firewall-enabled DOD network, accessible only to 
DOD employees and contractors who can provide two-factor authorization (henceforth referred 
to as the 
).
NMCCL Network
DCTs will be scanned and saved onto the NMCCL Network. Not all staff have access to the same 
folders on the network due to privacy reasons, therefore when study staff without access to the 
folder containing the scanned DCTs need to transcribe hard copy data into a spreadsheet, the 
DCTs will be encrypted, then sent via the DOD Secure Access File Exchange (SAFE; https://safe.
apps.mil/).
When transcribing data from the hard copies, data will be recorded in a spreadsheet in which 
patients are only identified by their Study ID. This file will also be stored on the NMCCL Network, 
although in a separate file location from the master list.
Files containing PII or PHI will be destroyed 6 years from IRB closure of the study in accordance 
with HIPAA regulations. The study team will work with IMD to employ hardware or software to 
enable sanitization or destruction of data following IMD policies and procedures of all electronic 
data.
Data will not be shared with any outside agencies.
All data will be de-identified prior to data analysis.
Is this a data repository?
  Yes  
  No
10.15  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents 
(either by the Investigator or through an established repository) for FUTURE research, address. 
How the specimens/data will be used, where and how data/specimens will be stored (including 

shipping procedures, storage plan, etc.), whether and how consent will be obtained, procedures 
that will fulfill subjects’ request as stated in the consent, whether subjects may withdraw their 
data/specimens from storage, whether and how subjects may be recontacted for future research 
and given the option to decline, whether there will be genetic testing on the specimens, who will 
have access to the data/specimens, and the linkage, the length of time that data/specimens will 
be stored and conditions under which data/specimens will be destroyed.
N/A
Is this a data repository?
  Yes  
  No
11.0
 
Statistical/Data Analysis Plan
11.1  Data Analysis Plan and Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses. Explain how missing data and outliers will be handled in the 
analysis. The analysis plan should be consistent with the study objectives. Include any subgroup 
analyses (e.g., gender or age group). Specify statistical methods and variables for each analysis. 
Describe how confounding variables will be controlled in the data analysis.
Analysis will be conducted using SAS 9.4 (SAS Institute, Cary NC) or SPSS 28 (IBM Corp, 
Armock NY). Inferential analyses will be considered significant if the corresponding p-value is 
less than 0.05, and all applicable tests will be two-tailed.
Numerical variables which satisfy normality (as demonstrated by the Kolmogorov-Smirnov test) 
will be reported in means and standard deviations while non-normal variables will be reported in 
medians and interquartile ranges. All categorical variables will be reported in counts and 
frequencies. Effect sizes will be reported in risk ratios with 95% confidence intervals.
Potential Covariates
Demographics and risk factors will be compared between the DCE and ICE arms. Numerical 
variables will be compared using Student’s t or Wilcoxon Rank Sum as appropriate. Categorical 
and ordinal variables will be compared with the χ2 Test of Independence, or if assumptions are 
not met, Fisher’s Exact. In cases where multiple categories may make Fisher’s Exact too 
cumbersome to calculate, a Monte-Carlo estimation will be used.
Demographics or risk factors for which significant differences between groups exist will be used 
as confounding or covariate variables in regression analyses.
Primary Outcome: Airway Contamination
The presence of airway contamination is a binary variable.
If there are significant demographics or risk factors, the presence of airway contamination will be 
analyzed using logistic regression to adjust for these covariates. Collinearity and separation of 
data points will be checked, and variables may be transformed (such as dummy variables for 
categorical variables) or combined to meet the assumptions necessary to proceed with the 
model. Unadjusted regressions (the effect of a single independent variable on the dependent 
variable) as well as an adjusted regression (the combined effects of multiple independent 
variables on the dependent variable) will be conducted.
If there are no significant demographics or risk factors, the presence of airway contamination will 
be compared between the DCE and ICE arms using the χ2 Test of Independence, or if 
assumptions are not met, Fisher’s Exact.
Secondary Outcome: Laryngeal Complications
Laryngeal complications are either binary (ability to phonate, presence of sore throat) or ordinal 
(sore throat, post-operative cough, and voice quality).
If there are significant demographics or risk factors, laryngeal complications will be analyzed 
using logistic regression or ordinal logistic regression to adjust for these covariates. Collinearity 

and separation of data points will be checked, and variables may be transformed (such as 
dummy variables for categorical variables) or combined to meet the assumptions necessary to 
proceed with the model. Unadjusted regressions (the effect of a single independent variable on 
the dependent variable) as well as an adjusted regression (the combined effects of multiple 
independent variables on the dependent variable) will be conducted.
If there are no significant demographics or risk factors, the ability to phonate will be compared 
between the DCE and ICE arms using the χ2 Test of Independence, or if assumptions are not 
met, Fisher’s Exact. The laryngeal complications measured ordinally will be compared between 
the DCE and ICE arms using the Cochran-Armitage test.
Secondary Outcome: Respiratory Complications
Respiratory complications are either binary (presence of cough, hypoxemia, obstruction, stridor 
or laryngospasm) or ordinal (cough severity, hypoxemia severity).
If there are significant demographics or risk factors, respiratory complications will be analyzed 
using logistic regression or ordinal logistic regression to adjust for these covariates. Collinearity 
and separation of data points will be checked, and variables may be transformed (such as 
dummy variables for categorical variables) or combined to meet the assumptions necessary to 
proceed with the model. Unadjusted regressions (the effect of a single independent variable on 
the dependent variable) as well as an adjusted regression (the combined effects of multiple 
independent variables on the dependent variable) will be conducted.
If there are no significant demographics or risk factors, the binary respiratory complications will 
be compared between the DCE and ICE arms using the χ2 Test of Independence, or if 
assumptions are not met, Fisher’s Exact. The respiratory complications measured ordinally will 
be compared between the DCE and ICE arms using the Cochran-Armitage test.
Secondary Outcome: Supplemental Oxygen
Supplemental oxygen was measured as either binary (need for supplemental oxygen) or numeric 
(time until oxygen administered).
If there are significant demographics or risk factors, the need for supplemental oxygen will be 
analyzed using logistic regression. Collinearity and separation of data points will be checked, and 
variables may be transformed (such as dummy variables for categorical variables) or combined 
to meet the assumptions necessary to proceed with the model. Unadjusted regressions (the 
effect of a single independent variable on the dependent variable) as well as an adjusted 
regression (the combined effects of multiple independent variables on the dependent variable) 
will be conducted.
If there are no significant demographics or risk factors, the need for supplemental oxygen will be 
compared between the DCE and ICE arms using the χ2 Test of Independence, or if assumptions 
are not met, Fisher’s Exact.
If there are significant demographics or risk factors, the time until supplemental oxygen is 
administered will be analyzed using linear regression. Collinearity and separation of data points 
will be checked, and variables may be transformed (such as dummy variables for categorical 
variables) or combined to meet the assumptions necessary to proceed with the model. 
Unadjusted regressions (the effect of a single independent variable on the dependent variable) 
as well as an adjusted regression (the combined effects of multiple independent variables on the 
dependent variable) will be conducted.
If there are no significant demographics or risk factors, the time until supplemental oxygen is 
administered will be compared between the DCE and ICE arms using the Student’s t-test or 
Wilcoxon Signed Rank, as appropriate.
11.2  Sample Size:
88
11.3  Total number of subjects requested (including records and specimens):
88
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 

be enrolled in each arm
Inflated Cuff Arm: 44
Deflated Cuff Arm: 44
11.5  Please provide a justification for your sample size
In a 2022 study of aspiration under general anesthesia, Mraovic et al [14] found that when the 
endotracheal tube cuff was inflated, secretions had migrated into the distal trachea in 13% of 
patients. Alternatively, once the cuff was deflated, 56% of patients had evidence of secretion 
migration. This study was small, consisting of only 50 patients, so conservate estimates were 
used to calculate sample size.
To detect a 30% decrease in patients experiencing aspiration (from 50% to 20%), at 80% 
power, where p < .05 is considered significant, we need 39 patients per group, for a total of 79 
participants. To account for a potential 10% loss to follow up, we will need to enroll 88 total 
participants.
12.0
 
Participant Information
12.1  Subject Population:
Healthy adults aged 18 to 50 years old undergoing scheduled, non-airway surgery at Naval 
Medical Center Camp Lejeune.
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel

Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Adults aged 18 to 50 years old
 
2 
Scheduled for surgery, not of the airway, head, or neck, with anticipated case 
duration of less than 3 hours
 
3 
American Society of Anesthesiologists (ASA) Physical Status Classification of 1 to 3
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Emergent surgery, or surgery requiring prone, sitting or lateral positioning
 
2 
Pre-existing laryngeal pathology, obstructive pulmonary disease, pulmonary 
hypertension, interstitial lung disease, active respiratory infection, recent 
pneumonia, uncontrolled asthma, or uncontrolled gastroesophageal reflux disease
 
3 
Known difficulties with general anesthesia, such as prior anaphylactic reaction, 
difficult intubation or mask ventilation
 
4 
Known allergy to iohexol or a previous severe reaction to any contrast agents
 
5 
Unfavorable airway examination, such as Mallampati 4, limited mouth opening, and
/or inability to extend neck
 
6 
Non-compliance with ASA Practice Guidelines for Preoperative Fasting
 
7 
Pregnancy
 
7 
Emergent surgery, or surgery requiring prone, sitting or lateral positioning
 
8 
Enrollment in another anesthesiology or surgery related interventional research 
study 
 
8 
Pregnancy
 
11 
Surgeries scheduled on Friday or a day immediately prior to a holiday
 

13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
Each calendar week, the PI will examine the scheduled surgery list for upcoming procedures for 
which the PI is the anesthesiologist performing general endotracheal anesthesia. The PI will 
review the procedure scheduled to determine if the patient is a potential candidate.
Potential candidates will be contacted via telephone by the PI. The PI will make three attempts to 
contact the patient. If the potential candidate answers the telephone, the PI will follow a basic 
recruitment script approved by the IRB. It is possible the patient may ask questions outside the 
scope of the script and the PI will answer to the best of his clinical judgment.
If the potential candidate expresses interest in the study, they will be provided with an electronic 
copy of the informed consent document (ICD) via email or file transfer system of their choice. 
This will allow the candidate time to consider their choice to participate in the study and review 
the document before signing.
No voicemails or messages will be left if the patient does not answer. If recruitment is low due to 
unanswered phone calls, we may submit an amendment to leave a voice message or send a text.
NMCCL.2024.L012 “Deflated vs Inflated Cuff Endotracheal Extubations”
RECRUITMENT TELEPHONE SCRIPT
Good morning/afternoon/evening, this is Dr. Michael Lee calling from Naval Medical Center Camp 
Lejeune. May I please speak with {Patient Name}? 
[PATIENT NOT AVAILABLE] 
This is not an urgent matter, and {patient name} does not need to call me back. However, is 
there a better time for me to them call back? (
)
record time and date to return the call
[PATIENT AVAILABLE] 
For your upcoming surgery, you will be receiving general anesthesia. I am reaching out to you 
today because you may be a candidate for a research trial that we’re conducting on how general 
anesthesia is done. This would be completely voluntary. Would now be a good time to tell you 
more about this trial?
[PATIENT NOT INTERESTED]
I understand. Thank you for your time. (
)
hang up, note to not call again
[PATIENT STATES NOT A GOOD TIME]
Is there a better time I can call to tell you more? (
)
record time and date to return call
[PATIENT AVAILABLE]
Thank you. As I mentioned earlier, for your upcoming surgery, you will be receiving general 
endotracheal anesthesia. This means that we will drift you off asleep with anesthetic 
medications, and then place a breathing tube into your windpipe. We will keep you asleep and 
comfortable with anesthetic medications while your surgery takes place. Once the surgery is 
complete, we will stop giving you anesthetic medications, and you will begin to awaken from 
anesthesia. Before you are wide awake, we will take the breathing tube out. The process of 
taking out a breathing tube is called extubation. You will then go to the post-anesthetic care unit, 
or PACU, to recover from anesthesia and surgery. 
Do you have any questions so far?
[IF YES]
(
)
listen to candidate’s questions and answer them
[IF NO]
Our research concerns how we take out breathing tubes. Modern breathing tubes have a balloon-
like cuff that we inflate inside your windpipe to make a seal. The cuff enables our ventilator 
machine to efficiently breathe for you. The cuff also keeps fluids from entering your lungs, such 
as your saliva and stomach juices. This cuff stays inflated during surgery. 
Once surgery is over, the standard practice is to deflate the cuff and then take out the breathing 
tube. The reason this is standard practice is because some doctors are concerned that keeping 
the cuff inflated as it is taken out might harm parts of your throat, like your voice box. However, 
right now there haven’t been any cases of inflated cuffs harming a person’s throat more than a 
deflated cuff. We do know that when the cuff is deflated, sometimes there are cases when the 
remaining fluids leak into the windpipe and lungs. 
Our research group wants to know if a different technique can reduce or prevent fluids from 
entering your lungs. We want to see if leaving the cuff inflated as we remove the breathing tube 
can do this. 

What questions do you have before I explain the steps of the study in detail?
(
)
answer candidate’s questions
If you were willing to participate in this study and are a suitable candidate, you would receive 
general anesthesia and undergo your scheduled surgery as planned. Towards the end of surgery, 
we would confirm that the breathing tube cuff was still safely inflated. We would then place a 
small amount of liquid contrast material in the back of your mouth. We use this contrast material 
so that we can find out later if any fluids entered your windpipe or lungs. 
When the contrast is put in your mouth, you would still be asleep under anesthesia with the 
breathing tube protecting your airway. We would then remove as much of the contrast material 
as possible, along with all other fluids, using our normal methods. 
Next, we would begin to wake you up from anesthesia. When it is safe to take the breathing tube 
out, we would either remove the cuff after deflating it or remove the cuff while it is still inflated. 
The way we remove the cuff will be selected at random. 
After the breathing tube is out, we would collect information about the quality of the extubation 
and about how well you are breathing. Then you would be transferred to the PACU. In the PACU, 
we would take a chest x-ray to see if any of the contrast material moved into your windpipe or 
down towards your lungs. 
Otherwise, you would proceed through recovery as normal. The day after your surgery, a 
member of the research team would call you to ask you about any symptoms you may be 
experiencing, like sore throat or hoarse voice. That would be the end of the research trial for 
you, and you would otherwise follow up with your surgeon as planned. 
What questions do you have?
(
)
answer candidate’s questions
Participation in this research trial is entirely optional. However, if you are willing to participate, 
we would like to email you a copy of our informed consent so that you may review it ahead of 
time. It has all the details about our study, as well as contact information if you have any more 
questions. You would not have to participate just because I sent you this information.
If you are willing to participate, I would meet with you before your surgery to answer any more 
of your questions. You would sign the informed consent document then, and that is when you 
would be entered into the study.  
Would you be interested in having me send you more information?
[PATIENT NOT INTERESTED]
I understand. Thank you for your time. (
)
hang up, note to not call again
[PATIENT INTERESTED]
(
)
get contact information to send informed consent document
I will send you an email shortly. Feel free to discuss this study with family or friends. I look 
forward to answering any other questions you have after you’ve had a chance to read the 
information. 
Do you have any other questions for me right now?
(
)
answer candidate’s questions
Thank you for your time today.
-------------------------------------------------------------------------------------------------------------
----
Name: 
Signature:
Date:
NOTE:
If the patient asks questions about the procedure itself, refer them to the appropriate service:
General Surgery          910.450.4760/910.450.4761
Orthopedics                910.450.4820/910.450.4821
Gynecology                 910.450.4561
13.2  Compensation for Participation:
None.
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
Each calendar week, the PI will examine the scheduled surgery list for upcoming procedures for 
which the PI is the anesthesiologist performing general endotracheal anesthesia. The PI will 
review the procedure scheduled to determine if the patient is a potential candidate. 
A HIPAA waiver has been submitted. 

13.4  Consent Process:   Revised Common Rule, Section 219.116:  General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 
(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes  
  No
Please explain the consent process:
The consent procedure will be performed by the study PI.
The PI will review his upcoming schedule weekly to identify patients who are undergoing 
procedures with expected duration of less than 3 hours, not of the head, neck or throat, and 
require general endotracheal anesthesia. A HIPAA waiver will be filed for the PI to review the 
charts of these potential candidates to confirm basic eligibility (such as age, ASA status and 
pregnancy status) and to collect the most recent phone number with which to contact patients.
Once the PI has identified eligible candidates, he will contact the candidate via telephone. The PI 
will explain the study methodology and its objectives. If the study candidate is amenable to 
participation, the PI will discuss the information contained in the informed consent document and 
explain the consent and study processes. The study candidate will be given an opportunity to 
discuss and ask any questions.
If the potential candidate expresses interest in participating in the study, they will be provided 
with an electronic copy of the informed consent document (ICD) via email or the file transfer 
system of their choice. This will allow the candidate time to consider their choice to participate in 
the study and allow them time to review the document before signing. Furthermore, contact 
information for the investigators will be provided in the event the study candidate requests 
further elaboration in the time interval between recruitment and day-of-surgery.  
On the day-of-surgery, prior to the procedure or administration of any sedating medications, the 
PI will briefly restate the study goals and procedures, using the informed consent document as a 
guide. He will ensure that all questions and concerns of the potential candidate are addressed. If 
the candidate volunteers to participate, the informed consent document will be signed by the 
participant and PI.
The participant will be enrolled in the study and the PI will assign the participant a Study ID 
number.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study
Participants will be able to withdrawal from the study up until they undergo general anesthesia. 
If the participant withdrawals before the administration of anesthesia, their data will not be 
collected.
Participants with whom anesthesiologists encounter difficult mask ventilation or difficult 
intubation will be excluded from analysis.  No further study data will be collected.  Extubation will 
be performed with a deflated cuff technique.

14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach 
of confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes
Potential Harms Associated with the Research Study
Breach of confidentiality is always a risk of conducting research. 
Potential Harms Associated with the Intervention
The literature does not currently support the unsubstantiated concern that ICE causes 
significantly more laryngeal injury than DCE.
The current standard anesthetic practice for extubation is to deflate the endotracheal tube cuff 
using a syringe prior to extubation [1]. While commonplace and nearly universally accepted, this 
practice is not based on evidence from randomized controlled trials [2] but is instead due to 
concern for laryngeal or vocal cord injury and arytenoid cartilage dislocation [3].  However, no 
publications exist in the medical literature that attribute laryngeal trauma directly to inflated cuff 
endotracheal tube extubation, as opposed to the process of extubation in general [4]. To the 
contrary, case reports that describe peri-operative extubation with unintentionally inflated cuffs 
all note the absence of negative outcome [5, 6].
Within the intensive care setting, unplanned extubation (including accidental extubation and self-
extubation) occurs at a rate of 3% to 16% of intubated patients or 0.1 to 3.6 per 100 days of 
mechanical ventilation [113, 14, 15, 16]. Estimates of national hospitalizations requiring 
mechanical ventilation approach 800,000, thereby placing the estimated number of unplanned 
extubations between 24,000 and 128,000 [17]. Presumably, the majority of these unplanned 
extubations are with inflated cuffs, and yet still no epidemic of laryngeal trauma from inflated 
cuff extubation exists. Furthermore, there have been no significant differences in laryngeal 
complications reported between planned and unplanned extubation in the intensive care 
population, suggesting that it is the endotracheal tube itself (and the process of placing it) that 
confers the risk of laryngeal complications, rather than the circumstances of its removal [18, 19].
Thus, we have no substantiated reason to believe that there are additional risks of harm in the 
ICE arm as compared to the DCE arm.
Potential Harms Associated with the Outcome 
Assessments
Airway contamination in non-obstetric adults, as defined as: 1] the detection of non-respiratory 
secretions in the trachea, bronchi or bronchioles, 2] development of new pulmonary symptoms, 
or 3] new abnormalities in chest radiographs within 24 hours following surgery, is an extremely 
rare complication of anesthesia.
To assess airway contamination, we are conducting an anterior-posterior chest x-ray to detect 
contrast material. This procedure is not standard of care, as it is typically only performed when 
aspiration is suspected. For the purposes of research, we will be performing x-rays on all patients 
regardless of suspected aspiration. Thus, there are potential risks associated with the 
administration of the contrast material and the chest x-ray.
Contrast Material (Iohexol)

By examining all patients regardless of symptoms, we are potentially subjecting patients to 
contrast aspiration to which they would not be otherwise exposed. While we have no reason to 
believe contrast would be aspirated at a different rate than oropharyngeal contents, to minimize 
these risks, we will use iohexol as the contrast material, which has fewer complications as 
compared to barium and is the preferred contrast material when aspiration is a risk [24-
30].  One accidental bronchography was obtained during the conduct of an iohexol-based 
swallow study in which 10 ml of iohexol was aspirated [35].  That patient experienced no 
respiratory distress and required no supplemental oxygen administration. Iohexol has an 
excellent safety profile even when deliberately introduced into the airway, as it is for 
tracheobronchography.  Case series describing iohexol for tracheobronchography encompass 
neonatal, pediatric, and adult patients under general anesthesia or sedation [31-34].  These case 
series all emphasize that no deteriorations in respiratory status were observed. 
Furthermore, it is possible that the patient may have an acute adverse reaction to the contrast 
agent. Iohexol is known for its lower likelihood of severe allergic reactions or other adverse 
events. The known potential complications using iohexol include nausea, vomiting, coughing, or 
headache. Hives and fever are rare, and life-threatening adverse events are rarely reported with 
iohexol. [46-49]
Chest X-Ray
The risks associated with x-rays are minimal. Radiographs do expose patients to radiation. No 
direct epidemiological data exists to support an increased cancer risk from exposure to the 
amount of radiation from a single chest x-ray, which is approximately 0.1mSv [50].
It is also possible that the chest x-ray may identify an incidental or unexpected finding unrelated 
to the study goals. These incidental findings may lead to further tests or evaluation.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel
Two anesthesiologists will be present at the time of extubation for airway intervention if 
necessary. The contrast material will only be instilled into the oropharynx after confirmation of 
endotracheal tube cuff inflation to a seal-generating pressure. Residual contrast material in the 
oropharynx will be cleared by suctioning prior to extubation. While no contrast material is 
entirely benign to the lungs, iohexol (Omnipaque) has been selected as the contrast agent likely 
to pose the lowest overall risk. It is a water-soluble non-ionic agent with animal and human data 
supporting its safety for bronchograms and swallowing studies assessing for aspiration. 
A Speech Pathologist will be the primary data collector for the post-operative day one data, 
allowing for prompt specialist evaluation in the event of significant laryngeal symptoms.
To reduce the risks of breach of confidentiality, data management precautions, as outlined in 
section 10.14 will be taken. 
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse
To reduce the risk of breach of confidentiality, data management precautions, as outlined in 
section 10.14, will be taken.

14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects
Based on an animal model, inflated cuff extubation may reduce airway contamination by 
oropharyngeal fluid. Tracheal aspiration, even micro-aspiration by orophearyngeal secretions, 
may increase the risk of pneumonia and other pulmonary complications. Leaving the 
endotracheal tube cuff inflated may effectively generate a vital capacity breath during 
extubation, maximizing oxygen reserves and facilitating an secretion-clearing cough. These 
theorized advantages may prolong the time to which supplemental oxygen is required as well as 
decrease airway/respiratory complications in the immediate post-extubation period.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
Patients undergoing scheduled surgeries will be recruited over the phone and the consent will be 
signed prior to surgery. NMCCL has established protocols for protecting patient privacy during 
phone calls and in the hospital, both of which will be followed during the applicable research 
activities. All staff involved in the research study have up to date HIPAA training.
Furthermore, to reduce the risk of breach of confidentiality, data management precautions, as 
outlined in section 10.14, will be taken. 
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 
results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 
results to appropriate military or civilian authorities and explain the potential impact on the 
subject
Should there be an incidental finding or adverse event, the Anesthesia staff, Data Monitor and PI 
will be immediately notified. The patient will then be fully evaluated and treated with appropriate 
consultations at NMCCL. As all participants are Tricare eligible by design, any and all necessary 
care will be covered by Tricare.
Adverse events will be reported to the IRB as per the CID SOPs.
The PI will be the ordering physician for all chest x-rays.  The results will then be reported to the 
PI.  The PI will then call the patient with any abnormal findings of concern and document a t-con 
in MHS Genesis for review by their PCM. 
15.0
 
Study Monitoring

15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
A DSMP should describe the plan to monitor the data to verify that the data are collected and 
analyzed as specified in the protocol. Include who will conduct the monitoring, what will be 
monitored, and the frequency of monitoring. It should also include the plan to ensure the safety 
of subjects
Though there have been no randomized controlled trials to assess the differences between ICE 
and DCE, literature does not currently support the unsubstantiated concern that ICE causes 
significantly more injury than DCE. Therefore, given the low risk of the intervention as compared 
to the control arm, there will be no data monitoring committee.
However, to ensure patient safety and data integrity, we will have a Data Monitor. The Data 
Monitor will be responsible for reviewing severe adverse events that require specialty consults, 
spot checking data entry for accuracy, and confirming that study protocols are being followed.
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short-
term management and any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event
Expected complications of extubation include respiratory complications (coughing, hypoxemia, 
airway obstruction, bronchospasm, stridor, and laryngospasm), laryngeal complications 
(hoarseness, dysphonia, sore throat, cough, and dysphagia), asymptomatic airway 
contamination, or supplemental oxygen. These complications will not be reported as they are 
expected and related to the process of extubation, which all participants will be undergoing. 
The following research related complications will be reported:
Symptomatic airway contamination (Incidence of 0.006%) 
Severe reaction to iohexol (Incidence 0.04%)
The following potential severe complications of extubation will be reported: 
Severe complications of general anesthesia, such as stroke (Incidence of 0.52% to 0.77%)
Reintubation (Incidence of 0.1%)
Unplanned ICU Admission (Incidence of 0.17%)
Death (Incidence of 0.001%)
The aforementioned adverse events and any unanticipated problems will be reported within 3 
business days to the IRB of record as required by NMCCL's CID SOPs. 

17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes  
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.3  Device Details:
Are device(s) in this research being used in accordance to the approved labeling?
Are device(s) in this research being used in a manner other than its approved labeling?
When adding a device indicate in the details section of the device if the use is either used in 
accordance to the approved labeling or in a manner other than it's approved labeling
View Details
Device Name
Teleflex Sheridan/HVT Murphy Eye Endotracheal Tube (Sizes 7.5/7.0) 
Manufacturer/Supplier of 
Device
Teleflex Sheridan 
Where will the Devices Be 
Stored
 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
 
18.4  Reporting Requirements for FDA-regulated research under IND and IDE:
Describe the process for complying with FDA regulatory requirements for adverse event 
reporting and adverse device effects reporting to the sponsor
N/A
18.5  Sponsor (organization/institution/company):
N/A

1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
9.  
10.  
11.  
12.  
13.  
14.  
15.  
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
20.1  References:
Cooper RM, O'Sullivan E, Popat M, Behringer E, Hagberg CA. Difficult Airway Society 
guidelines for the management of tracheal extubation. 
. 2013;68(2):217
Anaesthesia
Saidman LJ. Where is the evidence? Anesth Analg. 2007 Jul;105(1):285.
Suman S, Ganjoo P, Tandon MS. Difficult extubation due to failure of an endotracheal 
tube cuff deflation. 
. 2011;27(1):141-142
J Anaesthesiol Clin Pharmacol
Kamata M, Hakim M, Tobias JD. Residual volume in the cuff of the endotracheal tube 
when the pilot balloon is torn off instead of deflated using a syringe. Int J Pediatr 
. 2016;86:15-18
Otorhinolaryngol
Sriramka B, Natarajan A, Sharma K, Zubair S. Failed endotracheal tube cuff deflation due 
to unusual kinking of inflation tube. 
. 2023;23(4):241-243.
J Dent Anesth Pain Med
Hulme J, Agarwal S. Failure to deflate an endotracheal cuff. 
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Acta Anaesthesiol Scand
2008;52(5):719.
Shamsai J. A new technique for removal of endotracheal tube. 
. 2006;103
Anesth Analg
(4):1040.
Priebe HJ. Could "safe practice" be compromising safe practice? Should anesthetists have 
to deflate the cuff of the endotracheal tube before extubation?. 
. 2016;
Minerva Anestesiol
82(2):236-239.
Brown C. Endotracheal intubation in the dog. 
. 2007;36(2):23-24. doi:
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10.1038/laban0207-23
Ephgrave KS, Kleiman-Wexler R, Pfaller M, Booth B, Werkmeister L, Young S. 
Postoperative pneumonia: a prospective study of risk factors and morbidity. Surgery. 
1993 Oct;114(4):815-9.
Vance A, Hofmeister EH, Laas C, Williams J. The effects of extubation with an inflated 
versus deflated endotracheal tube cuff on endotracheal fluid volume in the dog. Vet 
. 2011;38(3):203-207.
Anaesth Analg
Baftiu N, Krasniqi I, Haxhirexha K, Domi R. Survey about the Extubation Practice among 
Anaesthesiologists in Kosovo. Open Access Maced J Med Sci. 2018 Feb 12;6(2):350-354.
Cosentino C, Fama M, Foà C, et al. Unplanned extubations in intensive care unit: Evidence 
for risk factors. A literature review. Acta Bio Medica: Atenei Parmensis. 2017;88(Suppl 5):
55.
de Groot RI, Dekkers OM, Herold IH, et al. Risk factors and outcomes after unplanned 
extubations on the ICU: A case control study. Crit Care. 2011;15(1):1#9.
Kiekkas P, Aretha D, Panteli E, Baltopoulos GI, Filos KS. Unplanned extubation in critically 
ill adults: Clinical review. Nurs Crit Care. 2013;18(3):123#134.

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da Silva PS, Fonseca MC. Unplanned endotracheal extubations in the intensive care unit: 
Systematic review, critical appraisal, and evidence-based recommendations. Anesth 
Analg. 2012;114(5):1003#1014.
Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The 
epidemiology of mechanical ventilation use in the United States. 
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Crit Care Med
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Boulain T, Association des Reanimateurs du Centre Ouest. Unplanned extubations in the 
adult intensive care unit: A prospective multicenter study. Am J Respir Crit Care Med. 
1998;157(4):1131#1137.
Atkins PM, Mion LC, Mendelson W, Palmer RM, Slomka J, Franko T. Characteristics and 
outcomes of patients who self-extubate from ventilatory support: a case-control study. Ch
. 1997;112(5):1317-1323. doi:10.1378/chest.112.5.1317
est
Whiffler K, Andrew WK, Thomas RG. The hazardous cuffed endotracheal tube--aspiration 
and extubation. S Afr Med J. 1982 Feb 13;61(7):240-1. 
Mehta S. The risk of aspiration in presence of cuffed endotracheal tubes. Br J Anaesth. 
1972 Jun;44(6):601-5.
Mraovic B, Hipszer B, Loeum C, Andonakakis A, Joseph J. Evaluation of continuous 
aspiration of subglottic secretions in prevention of microaspiration during general 
anesthesia: a randomized controlled pilot study. Croat Med J. 2022 Dec 31;63(6):553-
563. 
Cork RC, Depa RM, Standen JR. Prospective comparison of use of the laryngeal mask and 
endotracheal tube for ambulatory surgery. Anesth Analg. 1994 Oct;79(4):719-27.
Yan GW, Deng JF, Bhetuwal A, Yang GQ, Fu QS, Chen H, Hu N, Zeng H, Fan XP, Yan GW, 
Wu XL. A case report and literature review of barium sulphate aspiration during upper 
gastrointestinal examination. Medicine (Baltimore). 2017 Nov;96(47):e8821. 
Brick SH, Caroline DF, Lev-Toaff AS, Friedman AC, Grumbach K, Radecki PD. Esophageal 
disruption: evaluation with iohexol esophagography. Radiology. 1988 Oct;169(1):141-3. 
Claussen D. Omnipaque (iohexol). Gastroenterol Nurs. 1992 Jun;14(6):307-9.
Morcos SK. Review article: Effects of radiographic contrast media on the lung. Br J Radiol. 
2003 May;76(905):290-5. 
Sun J, Li Z. Study on the Correlation between Barium Radiography and Pulmonary 
Infection rate in the Evaluation of Swallowing Function. Clinics (Sao Paulo). 2018;73:
e182. 
Harris JA, Bartelt D, Campion M, et al. The use of low-osmolar water-soluble contrast in 
videofluoroscopic swallowing exams. 
. 2013;28(4):520-527.
Dysphagia
Hwang CH. Swallowing study using water-soluble contrast agents may increase aspiration 
sensitivity and antedate oral feeding without respiratory and drug complications: A 
STROBE-compliant prospective, observational, case-control trial. 
. 
Medicine (Baltimore)
2022;101(27):e29422.
Deutsch ES, Smergel E, Crisci K, Panitch H. Tracheobronchography in children. Laryngosco
. 1996;106(10):1248-1254. 
pe
Little AF, Phelan EM, Boldt DW, Brown TC. Paediatric tracheobronchomalacia and its 
assessment by tracheobronchography. Australas Radiol. 1996 Nov;40(4):398-403.
MacIntyre P, Peacock C, Gordon I, Mok Q. Use of tracheobronchography as a diagnostic 
tool in ventilator-dependent infants. Crit Care Med. 1998 Apr;26(4):755-9.
Sarkar P, Patel N, Chusid J, Shah R, Talwar A. The role of computed tomography 
bronchography in the management of bronchopleural fistulas. J Thorac Imaging. 2010 
Feb;25(1):W10-3.
Sivanandam LK, Verghese RJ, Balan S, Balamurugesan K. Accidental iohexol 
bronchography. 
. 2021;14(8):e244942.
BMJ Case Rep
Lai K. Chinese National Guidelines on Diagnosis and Management of Cough: consensus 
and controversy. J Thorac Dis 2014;6:S683-8.
Lin R, Zhu L, Pan X. Validation of the simplified cough symptom score in non-small cell 
lung cancer patients after surgery. Gen Thorac Cardiovasc Surg. 2022 Aug;70(8):735-
739. 
Hirano M. Clinical examination of voice. New York: Springer Verlag, 1981:81-4.
Dejonckere PH, Wieneke GH. GRBAS-scaling of pathological voices: reliability, clinical 
relevance and differentiated correlation with acoustic measurements, especially with 
central measurements. Proceedings of the 22nd IALP Congress. Hannover, Germany: 
1992.
Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a 
prospective study. Spine. 2002;27:2453–8.
Minogue SC, Ralph J. Laryngotracheal topicalization with lidocaine before intubation 
decreases the incidence of coughing on emergence from general anesthesia. Anesth 
Analg. 2004;99:1253–7.
Tung A, Fergusson NA, Ng N, Hu V, Dormuth C, Griesdale DGE. Pharmacological methods 
for reducing coughing on emergence from elective surgery after general anesthesia with 
endotracheal intubation: protocol for a systematic review of common medications and 
network meta-analysis. Syst Rev. 2019 Jan 24;8(1):32. 

43.  
44.  
45.  
46.  
47.  
48.  
49.  
50.  
Ghio A, Revis J, Smithson-Barrière D, Jarzé S, Giovanni A. Reliability and Correlations 
Between Overall Severity, Roughness and Breathiness in the Perception of Dysphonic 
Voices: Investigating Cognitive Aspects. J Voice. 2024 Jan;38(1):136-143. doi: 10.1016/j.
jvoice.2021.07.010.
De Bodt MS, Wuyts FL, Van de Heyning PH, Croux C. Test-retest study of the GRBAS 
scale: influence of experience and professional background on perceptual rating of voice 
quality. J Voice. 1997 Mar;11(1):74-80. 
Molfenter SM, Amin MR, Balou M, Herzberg EG, Frempong-Boadu A. A scoping review of 
the methods used to capture dysphagia after anterior cervical discectomy and fusion: the 
need for a paradigm shift. Eur Spine J. 2023 Mar;32(3):969-976.
Katayama H, Yamaguchi K, Kozuka T, et al. Adverse reactions to ionic and nonionic 
contrast media. A report from the Japanese Committee on the Safety of Contrast Media. 
Radiology 1990;175:621–8.
Wolf, GL, Arenson, RL, Cross, AP. A prospective trial of ionic vs nonionic contrast agents 
in routine clinical practice: comparison of adverse effects. AJR Am J Roentgenol, 1989;
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Caro, JJ, Trindade, E, McGregor, M. The risks of death and of severe nonfatal reactions 
with high- vs low-osmolality contrast media: a meta-analysis. AJR Am J Roentgenol, 1991;
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Lin EC. Radiation risk from medical imaging. Mayo Clin Proc. 2010 Dec;85(12):1142-6.
20.2  Abbreviations and Acronyms:

Page 1 of 13
Template Version Date: 08 Feb 23
You may be able to take part in this research study. This form gives you important information about the 
study.
Please take time to carefully look over this information. You should talk to the research team about the 
study and ask them any questions that you have. You can also talk to other people like your friends, 
family, or your personal doctor about whether or not to take part in this study.
Participation is voluntary. You do not have to take part in this research. It is your decision. You 
can also choose to stop participating at any time during the study.
1. KEY INFORMATION
General anesthesia is a treatment with medicine to make you unconscious for your surgery, so that your 
body will be completely still. This is sometimes called “being put to sleep” or “being put under.”
Most of the time, we use a breathing tube to help a machine breathe for you. The breathing tube has a 
cuff, which is like a small balloon. After the breathing tube is put in your airway, the cuff is inflated. 
This keeps the breathing tube in place and keeps fluids like saliva and stomach juices from getting into 
your airway. When we remove the breathing tube, that is called extubation.
Normally, doctors deflate the cuff before removing the breathing tube. This is called deflated cuff 
extubation. Some doctors worry that keeping the cuff inflated while it is removed can hurt your throat 
or vocal cords.
However, some doctors keep the cuff inflated when removing the breathing tube. This is called inflated 
cuff extubation. These doctors think that keeping the cuff inflated can help keep fluids from entering 
your airway.
Doctors have not studied if deflated cuff extubation is better or worse than inflated cuff extubation. The 
goal of this study is to see which type of extubation is better at keeping fluids from getting in your 
airway.
If you choose to take place in this study, you will get general anesthesia and have your surgery as 
planned. Near the end of your surgery, we would place a small amount of liquid at the back of your 
mouth. This liquid is called contrast material, and it is like a dye. The contrast material will help us find 
out if any liquid enters your windpipe or lungs. Then we will remove as much of the contrast material as 
we can, along with any other fluids, using our normal methods.
NAVAL MEDICAL CENTER CAMP LEJEUNE
CONSENT TO PARTICIPATE IN RESEARCH
Research Title: A single-center, patient- and assessor-blinded, randomized controlled trial 
to compare patient outcomes between Deflated and Inflated Cuff Endotracheal Extubations 
proceeding scheduled, non-airway surgery in healthy adults (DICEE)
Principal Investigator: CDR Michael Lee MD
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

Page 2 of 13
Template Version Date: 08 Feb 23
When it is safe to take the breathing tube out, we will either do a deflated cuff extubation or an inflated 
cuff extubation. This decision will be made at random, like by the flip of a coin.
Information will be collected about you, your surgery, and how well you are breathing. After surgery, 
we will take a chest x-ray to see if any of the contrast material is in your windpipe or your lungs.
Otherwise, everything else after your surgery would be normal. 24 to 48 hours after your surgery, a 
member of the research team will ask you about any symptoms you might have, like sore throat or a 
hoarse voice. That would be the end of the research study for you. You would follow up with your 
surgeon as planned.
Taking part in this study is optional. If you choose to take part, you will be in the study from the time 
you come into the hospital for surgery until about 24 to 48 hours after surgery.
There are risks any time you have a breathing tube removed after general anesthesia. However, there is 
no proof that the risks are different between deflated cuff extubation and inflated cuff extubation. It is 
possible, but unlikely, that you might have a reaction to the contrast material, such as an allergic reaction 
or a sore throat.
Also, the chest x-ray you would receive for this study uses a small amount of radiation. We are all 
exposed to radiation from natural sources every day, but any exposure to radiation can increase the risk 
of cancer over your lifetime. The amount of radiation from one chest x-ray is about the same you get 
from 10 days of daily life.
There are no guaranteed benefits to being in this study. However, you might be less likely to get fluids 
in your windpipe or lungs.
If you choose not to take part in this study, you will get general anesthesia and have your surgery as 
planned. Your doctor will determine whether to do deflated or inflated cuff extubation based on their 
experience and judgment.
Your decision will not affect your future care at Naval Medical Center Camp Lejeune (NMCCL). 
If you decide to take part in this research study, you will be asked to sign this document. Before you 
sign, be sure you understand what the research study is about. Please read all sections of the consent 
form, including the risks and possible benefits to you.
Please tell the researchers if you are taking part in another research study.
2. WHAT IS THE PURPOSE OF THIS RESEARCH STUDY AND WHO IS BEING ASKED 
TO TAKE PART?
You are being asked to take part in this research study because you are having surgery under general 
anesthesia.
General anesthesia is a treatment with medicine to make you unconscious for your surgery, so that your 
body will be completely still. General anesthesia also keeps you comfortable and controls your pain 
during the surgery. This is sometimes called “being put to sleep” or “being put under.”
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

Page 3 of 13
Template Version Date: 08 Feb 23
Most of the time, doctors will use a breathing tube to help a machine breathe for you. The breathing tube 
has a cuff, which is like a small balloon. After the breathing tube is put in your windpipe, the cuff is 
inflated. This keeps the breathing tube in place and keeps fluids like saliva and stomach juices from 
getting into your airway.
Your airway includes your windpipe and lungs. There are some cases when fluids can get into your 
airway, and you will still be fine. In other cases, when fluids get into your airway, the germs and 
bacteria can make you sick or hurt your lungs. Whether or not the fluid in your airway is harmful, it is 
called airway contamination.
When we remove the breathing tube, that is called extubation.
Normally doctors deflate the cuff before removing the breathing tube. This is called deflated cuff 
extubation. Some doctors worry that keeping the cuff inflated while it is removed might hurt your 
throat or vocal cords. However, there have not been studies to see if this is true.
Some doctors keep the cuff inflated when removing the breathing tube. This is called inflated cuff 
extubation. These doctors think that keeping the cuff inflated can help keep fluids from entering your 
airway.
Doctors have not studied if deflated cuff extubation is better or worse than inflated cuff extubation. The 
main goal of this study is to see which type of extubation is better at keeping fluids from getting in your 
airway. We will also look to see which type of extubation is better or worse at keeping you from having 
normal side effects of extubation, like a sore throat, coughing, or need for extra oxygen.
3. WHAT WILL HAPPEN IF YOU DECIDE TO BE IN THIS RESEARCH AND HOW LONG 
WILL IT TAKE?
There will be about 88 people taking part in the study at NMCCL over about 12 months. This study will 
take place for up to a week before the day of surgery (DOS) until 24 to 48 hours postoperative.
This study is looking at inflated cuff extubation. Inflated cuff extubation is when the balloon-like cuff of 
the breathing tube used during general anesthesia is removed while it is still inflated. Inflated cuff 
extubation has not been well-studied, because some doctors are worried that the inflated cuff could hurt 
someone’s throat or voice box. There haven’t been studies that show whether or not this is true.
If you choose to take part in this study, you will be in the study from the time you sign this document 
until about 24 to 48 hours after surgery. You will not have to make any extra hospital or doctor visits.
As part of the study, you will:
•
Have some information about you, like your age, biological sex, weight, height and medical 
history used for research.
•
Have liquid contrast material placed into your mouth while you are under general anesthesia.
•
Be assigned at random to one of the two extubation groups. Randomization is a process like 
flipping a coin and means you will have a chance of being assigned to either of the groups.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

Page 4 of 13
Template Version Date: 08 Feb 23
o
If you are in the deflated cuff extubation group, all air will be removed from the 
breathing tube cuff before the breathing tube is taken out.
o
If you are in the inflated cuff extubation group, air will be left in the breathing tube cuff 
when the breathing tube is taken out.
•
Have information about your general anesthetic, your surgery, and your recovery used for 
research. This will include things like if you have a sore throat, trouble swallowing, or need 
extra oxygen.
•
Receive a chest x-ray after the surgery.
•
Have a research team member ask you about your voice and throat 24 to 48 hours after your 
surgery. They will call you on the phone if you are home or visit your room if you are still in 
the hospital.
This study is blinded. For this study, it means that you will not know what group you are in. The people 
who will collecting information about after the procedure will also not know what group you are in. The 
only person who will know what group you are is Dr. Lee, because he will be doing the extubation. If 
there is an emergency, Dr. Lee will let people know what group you were in.
When the study is complete, the results of the study will not be automatically shared with you. But if 
you want to know the results, you can ask Dr. Lee about the study.
4. WHAT ARE THE RISKS OR DISCOMFORTS FROM BEING IN THIS RESEARCH?
Whether or not you take part in this study, there are risks from having using a breathing tube. But 
doctors do not know for sure if the risk of side effects from inflated cuff extubation is better, worse, or 
the same as deflated cuff extubation.
Common, but not serious risks from using a breathing tube can include:

Trouble swallowing,

Coughing,

Painful or sore throat,

Hoarse or weak voice,

Swelling in your voice box,

Bruising on or around your voice box,

Being unable to move or use your voice box, or

Parts of your voice box moving out of place.
These side effects happen in about 1 of every 3 patients who need a breathing tube for surgery. Some 
side effects can be mild and go away quickly. Other side effects can be more serious and permanent. 
Serious side effects are rare and happen in about 1 out of every 1,000 patients.
We do not know if these risks will be more or less common if you take part in this study.
To find out if fluids get in your airway, we are using contrast material and a chest x-ray. These both 
come with risks. You could be allergic to the contrast material, which could cause you to have mild 
problems, like feeling itchy, or severe problems, like not being able to breath. The contrast material may 
cause flatulence, diarrhea, nausea, vomiting, headache, or abdominal pressure from entering your
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

Page 5 of 13
Template Version Date: 08 Feb 23
stomach. The contrast material might also bother your airway, causing cough, wheezing, shortness of 
breath, fever, or uncomfortable breathing. About 1 to 3 patients in 100 may have minor side effects like 
these from the contrast material. More serious side effects can happen in about 1 in 2,500 patients.
Depending on the symptoms and severity, treatment may be required for any contrast material side 
effects.
The chest x-ray you would receive for this study uses a small amount of radiation. We are all exposed to 
radiation every day. However, any exposure to radiation can increase your lifetime risk of cancer. The 
amount of radiation from one chest x-ray is about the same you get from 10 days of daily life.
The chest x-ray could also find problem that you didn’t know about. This might mean you have to have 
more tests or doctors’ visits related to this new problem.
We make special efforts to protect your information. There is always a risk that someone who shouldn’t 
could get ahold of information in your medical records or other information that is collected for 
research.
There may also be other risks of taking part in this study that we do not yet know about.
5. ARE THERE BENEFITS TO TAKING PART IN THIS RESEARCH STUDY?
There may or may not be a direct benefit to you by taking part in this research study. Studies done in 
animals show that you might be less likely to get fluid in your airway. You may also be less likely to 
need extra oxygen after extubation. However, there is no guarantee that you will benefit from being in 
this research.
6. WHAT ARE THE ALTERNATIVES TO TAKING PART IN THIS RESEARCH?
Your alternative is to not take part in this study. If you choose not to take part, your anesthesia doctor 
will choose an extubation method based on their experience and judgment.
7. WILL YOU GET PAID FOR TAKING PART IN THIS RESEARCH STUDY?
No, you will not receive any compensation for participating in this study.
8. ARE THERE COSTS FOR TAKING PART IN THIS RESEARCH?
No, there are no costs to you for taking part in this research study.
9. IS THERE A SOURCE OF FUNDING?
No funding is being provided for this research study.
10. WHAT IS THE LOCATION OF THE RESEARCH?
Everything related to this study is going to take place at Naval Medical Center Camp Lejeune.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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11. ARE THERE ANY DISCLOSURES OF FINANCIAL INTERESTS OR OTHER 
COMMERCIAL RELATIONSHIPS?
The research study team doesn’t get any money for doing this research from companies or other funding 
groups.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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12. WHO WILL SEE MY INFORMATION (PRIVACY) AND HOW WILL IT BE 
PROTECTED (CONFIDENTIALITY)?
Your records related to this research study may only be shared in accordance with state and federal law, 
including the Federal Privacy Act, 5 U.S.C.552a, and its implementing regulations. DD Form 2005, 
Privacy Act Statement - Military Health Records, contains the Privacy Act Statement for the records.
You can locate and read the form online or a copy of the form can be given to you upon request. (Online 
at: https://www.esd.whs.mil/Portals/54/Documents/DD/forms/dd/dd2005.pdf),
The research team will keep your research records. These records may be looked at by staff from the 
NMCCL’s Anesthesiology Department, NMCCL’s Clinical Investigations, the Defense Health Agency, 
and the DoD. The committee responsible for protecting research participants, called the Institutional 
Review Board (IRB), may also look at your records as part of their duties. These duties include making 
sure that the research participants are protected. Confidentiality of your records will be protected to the 
extent possible under existing regulations and laws but cannot be guaranteed.
Procedures to protect the confidentiality of the data in this study include but are not limited to:

Locking paper copies of research data behind two locks. For example, paper will be in a locked 
office in a locked building, or in a locked cabinet/drawer in a locked office,

Using a coded number, or study ID number, instead of your name or medical record number on 
both any research data,

Saving computer files on the hospital’s private network, which:
o
Has a firewall, or a protection or barrier in the computer to protect information from 
being seen by people who shouldn’t see it, and
o
Needs two-factor authorization, which means that people who are allowed to see the data 
need both a special access card and a password,

The computer file that matches your name to your study ID number will have an extra password 
so that only Dr. Lee will be able to see it.
Researchers will make every effort to protect your privacy and confidentiality. However, there are risks 
of breach of information security and information loss. The researchers agree to safeguard your 
protected health information by using and disclosing it only as permitted by you in this consent or as 
directed by state and federal law.
Information gained from your participation in this research study may be published in literature, 
discussed for educational purposes, and used generally to further science. You will not be personally 
identified when your information is shared in these ways; all information will de-identified.
If applicable, a description of this clinical trial will be available online at http://www.ClinicalTrials.gov, 
as required by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of results. You can search this website at any time.
Complete confidentiality cannot be promised for military personnel, because information regarding your 
health may be required to be reported to appropriate medical or command authorities to ensure the 
proper execution of the military mission, including evaluation of fitness for duty.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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13.
WHAT HAPPENS IF THE RESEARCHERS SEE AN INCIDENTAL FINDING?
It is possible that while looking at your x-ray, the research team might see something strange that they 
did not expect to see. This is what is called an incidental finding.
The research team will let you know if they see an incidental finding. Depending on the type of 
incidental finding, they may contact you by phone or in person. If it might be serious, the research team 
will tell you right away.
The research team will also tell your primary doctor about the incidental finding. If you do not have a 
primary doctor, they will refer you to the right type or doctor for most tests.

An incidental finding may cause you to feel anxious

Since an incidental finding will be part of your medical record, it could be harder to get health or 
life insurance in the future.
The costs for any care that will be needed to diagnose or treat an incidental finding would not be paid for 
by this research study.
Any tests or care you might need because of the incidental finding would not be paid for by this study. 
You would be responsible for those costs. However, if you are a DoD beneficiary, you will have access 
to care through the Military Health System and TRICARE.
14.
WHAT HAPPENS IF YOU WITHDRAW FROM THIS RESEARCH?
The decision to take part in this research study is optional. This means you do not have to take part if 
you do not want to. You can also leave the research study at any time. If you choose not to take part in 
this research study or if you leave the study before it is finished, there will be no penalty or loss of 
benefits to which you are otherwise entitled.
If you do not want to keep taking part in the research study, you must tell Dr. Lee or another member of 
the research team.

If you tell the research team you do not want to take part before you have general anesthesia, 
then you will not be included in the research study at all.

If you tell the research team you do not want to take part after your surgery, any data that has 
already been collected will be used for the research study, but we will not collect any more data 
about you or your health.
Please note that taking back your consent to take part in this research does not take back the HIPAA 
Authorization that you will sign below. The HIPAA Authorization is how you give us permission to use 
or reveal your protected health information. To take back your authorization, please send a letter to Dr. 
Lee.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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Dr. Lee may stop you from taking part in this research study at any time if he thinks it is in your best 
interest. For example, if there are any problems giving your general anesthesia, or if there are any 
problems with your surgery, Dr. Lee may decide to take you out of the study.
15.
WHAT HAPPENS IF YOU ARE INJURED AS A RESULT OF THIS RESEARCH?
If you think that you have gotten hurt because you were in this research study, you need to tell Dr. Lee. 
His contact information is below.
A Department of Defense (DoD) healthcare beneficiary is someone who is able to get treatment from 
the Military Health System (MHS). This might be because they are or were in the military, or because 
their spouse or parent was in the military.
If you are injured because you took part in this research study and you are a DoD healthcare beneficiary, 
you will be able to get treatment from the MHS for as long as you are DoD healthcare beneficiary. This 
can include free medical care at a DoD hospital or clinic. If there is not room for you at the closest 
hospital or clinic, you may have to travel to a hospital or clinic farther away.
Travelling to and from hospitals or clinics will not be provided or paid for by DoD. If you do not have 
TRICARE insurance, the DoD cannot pay you back for any medicals bills that you might get. You will 
not get money if you are hurt in this research study.
You are not waiving any legal rights if you sign this form.
HIPAA AUTHORIZATION
A HIPAA Authorization is how you give us permission to use or reveal your health information.
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, as implemented by the 
DoD, permits the MHS to use or reveal your health information with a valid Authorization. The MHS is 
defined as all DoD health plans and DoD health care providers that are organized under the 
management authority of, or in the case of covered individual providers, assigned to or employed by, the 
Defense Health Agency (DHA), the Army, the Navy, or the Air Force. A valid Authorization must include 
the core elements and required statements as contained below.
The information above gives you the information you need to consent, or agree, to take part in the 
research study. This consent document also describes why we need to use or share your health 
information.
Below is the information you need to decide if you want to give us permission to use or reveal your 
health information. Please read it and ask questions about anything you don’t understand before 
deciding to give us permission. If you do not want to give us permission to use and share your health 
information, you do not have to. However, you will not be able to participate in this research study.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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a. What health information will be used or disclosed?

Your name and medical record; which will allow us to order the chest x-ray after your surgery 
and to look up your results afterwards,

Your phone number (if you have left the hospital) or room number (if you have not left the 
hospital); which will allow us to follow up with you 24 to 48 hours after your surgery

Information about your surgery and the general anesthesia used; which will help us understand 
who might benefit from this research, and

How well you feel and any side effects you have after surgery; this will help us compare the 
two types of extubation.
b. Who will be authorized to use or disclose (release) your health information?
Your health information may be use or shared by Naval Medical Center Camp Lejeune (NMCCL), 
which is sometimes also known as the Navy Medicine Readiness & Training Center at Camp Lejeune.
c.
Who may receive your health information?

Study staff who are helping with this research study

NMCCL’s Clinical Investigations Department, which is the department that helps doctors and 
nurses do research, and

The Institutional Review Board, which is the group that makes sure research on humans is safe 
and ethical.
d. What if you decide not to sign this Authorization?
You do not have to sign this Authorization, but if you do not, you will not receive research-related 
treatment. The MHS will not refuse treatment that is not part of this study, payment, enrollment, or 
eligibility for benefits based on whether you sign this Authorization.
e.
Is your health information requested for future research studies?
No, your health information is not requested for future research studies.
f.
Can you access your health information during the study?
You may have access to your health information at any time, unless your identifiers are permanently 
removed from the data.
g. Can you take back this authorization?

You may change your mind and take back your Authorization at any time. However, if you take 
back this Authorization, any person listed above may still use or share any already obtained health 
information as necessary to maintain the integrity or reliability of this research.

If you take back this Authorization, you may no longer be allowed to take part in this research 
study.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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
If you want to take back your Authorization, you must write to: 
CDR Michael Lee MD
Naval Medical Center Camp Lejeune 
Department of Anesthesia and Pain Medicine 
100 Brewster Blvd
Camp Lejeune, NC 28745
h. Does this Authorization expire?
Yes, it expires at the end of the research study.
i.
What else may you want to consider?

No publication or public presentation about the research described above will reveal your 
identity without another signed Authorization from you.

If all the information that does or can identify you is removed from your health information, the 
remaining de-identified information will no longer be subject to this Authorization and may be 
used or shared for other purposes.

In the event your health information is disclosed to an organization that is not covered by 
HIPAA, the privacy of your health information cannot be guaranteed.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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CONTACT INFORMATION
Principal Investigator (PI)
The Principal Investigator or a member of the research study team will be available to answer any 
questions throughout this study.
Principal Investigator:
CDR Michael Lee MD
Phone:
(910) 450-4786
Mailing Address:
Naval Medical Center Camp Lejeune 
Department of Anesthesia and Pain Medicine 
100 Brewster Blvd
Camp Lejeune, NC 28745
Clinical Research Coordinator:
Kathiusca Chalas-Reid BS 
Phone:
(910) 450-5082
Mailing Address:
Naval Medical Center Camp Lejeune 
Clinical Investigations Department 
100 Brewster Blvd
Camp Lejeune, NC 28745
Naval Medical Center Portsmouth (NMCP) Human Research Protection Program (HRPP) Office
The Human Protections Administrator (HPA) will be available to answer questions or discuss concerns 
you may have about this research study.
Human Protections Administer:
Chemely Walker MS 
Phone:
(910) 450-3460
Institutional Review Board (IRB) Office
If you have any questions about your rights as a research participant or if you have concerns or 
complaints about the research study, you can contact the office responsible for ensuring research 
participant protection, the Institutional Review Board (IRB).
Naval Medical Center Portsmouth 
620 John Paul Jones Circle 
ATTN: CID
Portsmouth, VA 23708
(757) 953-5939
usn.hampton-roads.navhospporsva.list.nmcp-irboffice@health.mil
IF THERE IS ANY PORTION OF THIS DOCUMENT THAT YOU DO NOT UNDERSTAND, ASK 
THE RESEARCHER BEFORE SIGNING. YOU MAY CONSULT WITH YOUR PERSONAL 
DOCTOR OR LEGAL ADVISOR, IF YOU WISH.
A signed and dated photocopy of this document will be given to you.
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025

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SIGNATURE OF PARTICIPANT
SIGNATURE OF INDIVIDUAL ADMINISTERING CONSENT
(Can only be signed by an investigator approved to administer consent)
SIGNATURES
Your signature below indicates that:

You authorize the Military Health System to use and reveal your health information for the 
research purposes stated above as described in the HIPAA Authorization;

You have read (or someone has read to you) the information in this consent including the 
HIPAA Authorization;

You agree that you have been provided time to read the information describing the research 
study in the consent form. The content and meaning of this information has been explained to 
you. You have been provided with the opportunity to ask questions

You voluntarily consent to take part in this research study.
By signing this form, I have not given up any of my legal rights as a research participant.
Printed Name of Participant
/
/
Signature of Participant
Date (DDMMMYYYY)
Printed Name of Administering Individual
/
/
Signature of Administering Individual
Date (DDMMMYYYY)
NMCP IRB Approval
IRB NUMBER: NMCCL.2025.0007
IRB APPROVAL DATE: 04/24/2025