A Prospective Comparison of the Disposable I-view Versus the Durable Video Laryngoscopes in the Emergency Department
Conditions: Intubation; Difficult or Failed, Airway Obstruction
Sponsor: Brooke Army Medical Center

 
 
 
A PROSPECTIVE 
COMPARISON OF THE 
DISPOSABLE I-VIEW 
VERSUS THE DURABLE 
VIDEO 
LARYNGOSCOPES IN 
THE EMERGENCY 
DEPARTMENT
March 8, 2021 
NCT: TBD 
      

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
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PROTOCOL TITLE: A prospective comparison of the disposable i-view versus the durable video 
laryngoscopes in the emergency department 
 
SECTION A:  RESEARCH TEAM AND LOCATIONS 
 
A1.  RESEARCH TEAM 
 
 
 
A2.  ROLES AND RESPONSIBILITIES 
      
       A2.1 Principal Investigator   
 
            Name: Steven Schauer 
            Study Responsibilities: Responsible for the conduct of the study in accordance with the protocol.  
Responsible for the conduct of the study in accordance with the protocol.  Maintenance of a list of appropriately 
qualified persons to whom significant study-related responsibilities have been delegated. 
 
        A2.2 Associate Investigator(s) 
 
           Name(s): N/A 
          Study Responsibilities: N/A 
 
      
Study Role 
Institution/Company and Contact Information 
Sponsor 
Organization/Institution/Company: N/A 
Address:  N/A 
Point of Contact:  N/A 
     Name and Degree:  N/A 
    Title:  N/A 
Phone Number:  N/A 
Email: N/A 
 
Principal Investigator 
Name, Rank, and Degree: Steven Schauer, MAJ, DO 
MSCR 
Title: Physician 
Institution: US Army Institute of Surgical Research 
Address: 3698 Chambers Pass, JBSA Fort Sam 
Houston, TX 78234 
Phone Number: 210-771-0706 
Email: steven.g.schauer.mil@mail.mil 
 
Associate Investigator(s) 
 
Name, Rank, and Degree:        
Title:        
Institution/Company:        
Address:        
Phone Number:        
Email:        
 
Ombudsperson 
 
Name, Rank, and Degree:  N/A 
Title:  N/A 
Institution/Company:  N/A 
Address:  N/A 
Phone Number:  N/A 
Email:  N/A 

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Date: 08 March 2021 
 
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        A2.3 Ombudsperson   
 
            Name(s): N/A 
            Study Responsibilities: N/A 
 
 A3.  RESEARCH LOCATIONS 
 
US Army Institute of Surgical Research 
Brooke Army Medical Center 
 
A4.  MULTISITE RESEARCH 
 
Lead Site: 
Lead Site Investigator: 
IRB that will review for the lead site: 
Function/Role of Lead Site: 
 
Performance Site: 
Performance Site Investigator: 
IRB that will review for the Performance Site: 
Function/Role of Performance Site: 
 
 
 
SECTION B:  RESEARCH METHODOLOGY 
 
B1.  ABSTRACT 
 
The US Military is rapidly transitioning into preparing for multi-domain operations.  Previous data demonstrates 
that the most common airway replaced in the prehospital combat setting is endotracheal intubation.  Previous 
studies have suggested that video laryngoscopy (VL) is superior to direct laryngoscopy (DL), which is most 
prominently noted in novice users.  However, the current durable equipment video laryngoscopes are very 
expensive and cost prohibitive for dispersion around the battlefield.  The i-view is a novel video laryngoscope 
that is marketed for VL and is inexpensive and disposable.  Both the durable VL and the i-view are already in 
use in our emergency department (ED).  We are also already collecting data using these devices as part of an 
approved protocol for an airway registry.  We are seeking to utilizing a clinical rotating protocol to compare 
these two devices in the emergency department. 
 
B2.  BACKGROUND AND SIGNIFICANCE 
 
The emergency department (ED) at the Brooke Army Medical Center (BAMC) has collecting data under 
protocol C.2015.140 for an airway registry and is part of our routine business operations.[1, 2]  The registry is 
primarily targeted at collecting data on every intubation that happens in the ED.  Our department has been 
capturing data under this protocol for several years and all our staff are voluntarily providing case report form 
data.  We will leverage the experience with this previous study to support this current protocol.  We are seeking 
to conduct this study over-the-top of that protocol in the form of a clinical rotating protocol. 
 
Effective prehospital interventions for combat injuries are critical for combat casualty survival. Airway 
compromise is the second leading cause of potentially preventable death in the prehospital, combat setting – 
second only to hemorrhage.[3, 4]  Airway skills can be difficult to obtain and maintain for those in the 
prehospital combat setting.[5]  The prehospital, combat environment is chaotic with significant challenges not 
present in the fixed-facility setting.  Video laryngoscopy (VL) came about in the early 2000s.  VL is a device 
that allows the operator to get a view of the intubating airway anatomy indirectly through a camera that projects 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
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onto a monitor.[6, 7]  While definitive evidence is lacking, observational evidence suggests that VL is superior 
to DL.[8, 9] 
 
The US military forward stages the GlideScope® VL to many of the Role 2s and Role 3s, however, the 
Glidescope is not part of the sets, kits and outfits (SKO) for the Role 1 or Role 2 (without surgical team 
augmentation).  However, the cost of acquiring this device has been cost prohibitive to push far-forward to all 
locations of care early in the chain-of-survival.  A VL device is on the market – the i-view® 
(https://us.intersurgical.com/info/i-view) - which is fully disposable and single-use.  The device costs 
approximately $100 (USD) which is fraction of the cost of a GlideScope which the Army pays $12,292.67 per 
device. (NSN 6515-01-572-7262, ZLIN Z05814)  Moreover, it is one-time use and disposable.  If an i-view 
device malfunctions or gets used in a far-forward area it is simply disposed of, whereas a Glidescope requires 
specialized skills to repair them if it malfunctions as well as proper cleaning equipment.  Due to its inexpensive 
design, the i-view would be an ideal device to push to far-forward areas where maintenance, battery charging, 
repairs and stocking of accessories would become much less challenging. 
 
In our department we routinely use VL devices for intubation including the reusable GlideScope and Storz 
systems.  The i-view is disposable VL device and is already in use in our ED as part of routine clinical care.[10]  
This FDA-approved device is technically equivalent and we are using it in the FDA-cleared manner.  However, 
it remains unclear whether it performs similarly in a pragmatic, clinical environment.  We seek to determine if 
this device has similar performance characteristics in an emergency airway management setting. 
 
B3.  MILITARY RELEVANCE 
 
Airway obstruction is cited as the second leading cause of potentially preventable death on the battlefield.[4]  
Relative to hemorrhage, there has been relatively little scientific development for airway management on the 
battlefield.  Direct laryngoscopy is a challenging skill to develop and maintain which is a primary reason why it 
is not in the combat medic armamentarium.  However, the advent of video laryngoscopy has significantly 
improved intubation success, likely side-stepping some of the skills required for direct laryngoscopy.  Until now, 
dispersion of video laryngoscopes across the battlefield into the combat medic aid bags has been cost 
prohibitive.  A new video laryngoscope, the i-view, is single-use and inexpensive – a potentially feasible 
technology for the far forward medical provider. 
 
B4.  OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS 
 
We are seeking to implement a clinical rotating protocol in which we will use alternating months for which VL 
device is to be used comparing the i-view to the reusable devices within our department. 
 
We are seeking to answer the following questions: 
(1) Does the i-view have similar first pass success rates compared to the reusable VL devices (e.g. 
GlideScope, C-Mac)? 
(2) Does the i-view have similar attempts required for placement compared to the reusable VL devices? 
B5.  RESEARCH PLAN 
 
       B5.1  Research Design 
 
We are seeking to conduct a prospective study comparing outcomes between the disposable i-view and our 
other reuseable VL devices. 
 
      B5.2  Research Subjects/Population(s)    
 
                B5.2.1  Subject Population(s) 
 
We are seeking all patients undergoing intubation for which the clinician chooses to use VL. 
 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
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                B5.2.2  Number of Subjects, Records, and/or Specimens 
 
We are seeking all encounters for which a VL intubation happens over the course of 2 years.  Our limit will be 
based on the number of times the procedure occurs.  Based on previously published data, we are estimating 
~200 intubations with 55% using VL per year based on our previous experience.[2] 
 
               B5.2.3  Inclusion Criteria 
 
We are seeking any encounter for which the patient undergoes VL intubation as part of routine clinical care.   
 
               B5.2.4  Exclusion Criteria 
 
No intubation will be excluded so long as VL is used.  
 
      B5.3  Research Procedures 
 
Intubation Procedure 
All intubations will be performed at the direction of the attending clinician.  The 
decision to intubate is based purely on clinical factors by the primary team.  
The decision to use VL device will be at the direction of the clinical team.  No 
patient will be recruited specific for this procedure. 
Clinical Rotating Protocol 
Currently in our emergency department, there are multiple VL devices that are 
already in use.  These devices include the i-view as well as multiple reusable 
VL devices such as the GlideScope and the Storz C-Mac system.  To ensure 
that we get high quality data, we are seeking to implement a clinical rotating 
protocol in which we will alternate months.  For the clinical rotating protocol, 
one month will be the i-view and the next month will be the durable VL 
devices (e.g. January will be i-view, February will be the durable VL devices).  
As part of the clinical rotating protocol, we will place clinician-facing signage to 
the clinician work areas, on the airway boxes, and on the equipment in the 
department indicating which device is for that month if choosing to participate 
in the study.  During the i-view month we may use a colored bag over the 
durable VL devices.  Of note, our devices are routinely covered in a protective 
bag to keep it clean when not in use (e.g. aerosolized COVID, etc.)  During 
the durable VL month we will place signs on the i-view device indicating that it 
is not an i-view month.  We will use educational reminders to the staff about 
the protocol schedule and the purpose of the study throughout.  We must 
note, however, the devices will remain in the department should the attending 
clinician need to break the protocol and obtain any of the devices.  We will 
ensure that clinicians are able to access any of the equipment that they may 
want to utilize easily during emergent situations. 
Data Collection 
Data will be collected using the standardized data collection form that gathers 
routine healthcare data in a standardized form and ensures that the study 
team can identify intubations that occur.  That information will then be linked 
to patient outcome data extracted by study team members. 
 
      B5.4  Data Collection 
 
Data Element/Variable 
Source 
Operational Specific 
Demographics, procedural data, 
complications, procedural 
operator data 
Case report form 
The data will be extracted into a 
Microsoft Excel database 
Outcome data – Please see data 
variable collection appendix 
listed below 
Case report form/T-system/trauma 
flow 
sheets/AHLTA/Impax/Essentris/MHS 
The data will be extracted into a 
Microsoft Excel database 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
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Genesis 
 
     B5.5  Managing Data and/or Human Biological Specimens for this Research 
 
Data will be documented using the enclosed case report form which is the same form already in use for BAMC 
protocol C.2015.140.   This will ensure that our department personnel are already familiar with the 
documentation, the flow of documentation, and minimizing duplication of efforts.  Upon completion of case 
report form, it will be combined with the data collection from the EMR and collated into a study database using 
Microsoft Excel using the same sequential numbering scheme.  This dataset will be stored on government-
issued computers and/or IMD-approved network shared drives available to the study team members.  If data 
needs to be transmitted electronically, we will use official email communications or and approved file transfer 
system. 
 
      B5.6  Managing Data and/or Human Biological Specimens for Future Research 
 
N/A – This section is not applicable 
 
      B5.7  Devices, Drugs, Dietary Supplements, Nutritional Supplements, And Biologics 
 
                B5.7.1  Devices 
 
                             5.7.1.1 FDA-approved device being used in this research according to the approved 
labeling 
 
1. GlideScope (https://accessgudid.nlm.nih.gov/devices/00879123006400) 
2. Storz C-Mac (https://accessgudid.nlm.nih.gov/devices/04048551409381) 
3. i-view (https://www.intersurgical.com/content/files/108253/-1977057700) 
 
                              5.7.1.2 FDA-approved device being used in this research in a manner other than its 
approved labeling 
 
N/A – This section is not applicable.  
 
 
 
      5.7.1.3 Any device not approved by the FDA 
 
N/A – This section is not applicable.  
 
                B5.7.2  Drugs 
 
                             B5.7.2.1 FDA-approved and used in accordance with the approved labeling 
 
N/A – This section is not applicable.  
 
                             B5.7.2.2 FDA-approved and used in a manner not in accordance with its approved 
labeling 
 
N/A – This section is not applicable.  
 
                             B5.7.2.3 Any drug not approved by the FDA 
 
N/A – This section is not applicable.  
 
B8  Statistical Analysis 
 
          B5.8.1  Sample Size Estimation 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
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A power analysis in SAS version 9.4 (SAS Institute, Cary, NC) indicated that a total sample of 122 would be 
needed to find that the i-view is non-inferior to the reusable VL if the expected outcome rate (proportion of 
patients experiencing first-pass success) for the i-view is 87%, the expected outcome rate for the reusable VL 
is 92%, the noninferiority margin is 5%, power is 80%, and alpha is 5%. 
 
B5.8.2  Data analysis 
 
We will use the Farrington-Manning score test for non-inferiority to test the first two hypotheses (that the i-view 
has a non-inferior proportion of patients experiencing hypoxic events, and that the i-view has a non-inferior 
first-pass success rate compared to the reusable VL devices). The Farrington-Manning score test computes 
the proportion (risk) difference and 90% confidence interval (for a one-sided test) with regards to a 
predetermined non-inferiority limit.  We will use pairwise deletion to handle missing data points (i.e., will only 
exclude observations if missing data relevant to the specific analysis).  Moreover, we may perform regression 
modeling to adjust for confounders.  We performed all statistical analysis using Microsoft Excel (version 10, 
Redmond, Washington) and JMP Statistical Discovery from SAS (version 13, Cary, NC) or another available 
commercial software package.  We will present continuous variables as means and 95% confidence intervals, 
non-parametric continuous variables and ordinal variables as medians and interquartile ranges, and nominal 
variables as percentages and numbers.  Significance will be set at p=0.05.  We will compare binomial variables 
using the Chi-square test, normally distributed continuous variables using the Student’s t-test, and non-
parametric and ordinal variables using the Wilcoxon Rank sum test. 
 
 
 
SECTION C:  HUMAN RESEARCH PROTECTIONS 
 
C1.  RECRUITMENT AND CONSENT 
 
       C1.1  Identification and Selection of Subjects 
 
Patients will not be specifically recruited for this study.  The decision to perform an intubation using VL will be 
purely at the direction of the attending clinician. 
 
       C1.2  Recruitment Process 
 
N/A – This section is not applicable.  
 
       C1.3  Eligibility 
 
N/A – This section is not applicable.  
 
       C1.4  Consent Process 
 
We are seeking a wavier of consent for this clinical rotating protocol as we have done with BAMC protocol 
C.2015.140.  All the devices of interest in this study are already in use in the ED and, while we are seeking to 
establish a clinical rotating protocol, clinicians can always break the protocol if indicated per their discretion.  
The procedure itself – emergency intubation – does not normally require consent in the emergency setting. 
 
                 C1.4.1  Research involving subjects with cognitive impairment or who lack capacity to 
provide informed consent 
 
N/A – This section is not applicable.  
 
                 C1.4.2  Research involving non-English speaking subjects 
 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
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N/A – This section is not applicable.    
 
                 C1.4.3  Research involving a waiver of the requirement to obtain informed consent OR 
alteration of the elements of informed consent 
 
The research involves no more than minimal risk to the subjects; and 
The waiver or alteration will not adversely affect the rights and welfare of the subjects; 
 
We are seeking to capture data that is part of routine healthcare operations.  The data that we are capturing 
represents data that is routine in the clinical setting and thus does not elevate the risk above that of routine 
patient care.  The clinical rotating protocol is using devices that are already in use in the department, are being 
use for their FDA cleared indications, and are all considered technically equivalent devices.  The intubation 
procedure itself is purely at the direction of the attending clinician. 
 
The research could not practicably be carried out without the waiver or alteration;  
 
We are specifically seeking out encounters in which an intubation occurs under this clinical rotating protocol.  
Intubations are only performed in patients that are critically ill and unable to participate in the consent process.  
We routinely perform these procedures without consent due to their underlying illness, and thus it would be 
impractical to attempt to consent them for the purpose of a clinical rotating protocol using devices that are 
already in use in the department. Moreover, attempting to consent them would result in delays in their care. 
 
Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 
 
Many of the patients that we are intubating are critically ill and not expected to survive.  As such, it would be 
impractical to attempt to provide them with information on a procedure that occurred as part of their routine 
clinical care. 
 
                 C1.4.4  Research involving a waiver of the requirement for investigator to obtain a signed 
consent form 
 
N/A – This section is not applicable.  
 
                 C1.4.5  Waivers of assent or parental permission when the research involves children 
 
N/A – This section is not applicable.  
 
                 C1.4.6  Research involving data collection for the USAMRDC Volunteer Registry Database 
 
N/A – This section is not applicable.  
 
C2.  COMPENSATION FOR PARTICIPATION 
 
Patients will not be compensated for participation as we are only collecting data in conjunction with routine 
clinical care. 
 
C3.  WITHDRAWAL FROM RESEARCH PARTICIPATION 
 
For the clinician centered data we do not anticiapet any withdrawal form the study.  We have been collecting 
data on airway interventions since 2015 as part of BAMC protocol C.2015.140 without any enconters for which 
a clinician asked that we cease data collection, declined participation, or asked that their data be withdrawn. 
However, in the event that a clinician asks to be withdrawn we will will only use their CRFs that were collected 
up to that point.  If a reason is provided, we will document such. 
 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
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For the patient EMR-based data we do not anticipate any patient withdrawal as we are seeking a waiver of 
informed consent and HIPAA waiver and thus they will likely not be aware of the study.  However, in the event 
that a patient does request withdrawal in writing to the PI or a study team member we will cease data collection 
from that point forward.  Data that was already collected will still be retained for use.  Since the overwhelming 
majority of our data comes from medical records review, we cannot make any changes, removal, or revisions 
to the data in the EMR system even if the patient were to request such.      
 
C4.  PRIVACY FOR SUBJECTS 
 
We are not intending any direct interaction between study team members and subjects for the study with the 
exception of the clinical personnel.  They may interact with the subjects only for routine healthcare and will not 
be for the purposes of this study.  As we are requesting a HIPAA waiver and consent waiver, additional privacy 
for recruitment and such will not be required and standard measures for privacy will be maintained per usual 
methods for healthcare delivery.  The data will be maintained and stored as outlined. 
 
C5.  CONFIDENTIALITY PROCEDURES FOR RESEARCH RECORDS, DATA, HUMAN BIOLOGICAL 
SPECIMENS 
 
The hard-copy forms will be immediately deposited into a secured lock-box in the ED and destroyed by 
shredder once entered in the database(s).  The data collection tool is password protected, encrypted 
Regarding the component of the study using data to include the case report form, these will include minimal 
PHI in the form of a patient sticker that we routinely use for patient care labeling.  The CRF data will be 
converted into an electronic database and linked with outcome data. Please see data variable collection 
appendix listed below. Data will be stored on a password-protected Excel database maintained on a 
government computer for the period of the study protocol.  All of these forms will also be destroyed 
immediately after entry into the Excel database. 
 
C6.  RISKS OF HARM, MEASURES TO REDUCE THE RISKS OF HARM, AND BENEFITS OF 
PARTICIPATION 
 
       C6.1 Risks of Harm 
 
No procedures or interventions are being performed because of this study.  We are only seeking to answer a 
specific research question as part of a clinical rotating protocol using devices that are already in use and 
indicated for the same situations.  While the critical nature of their illness and the mere need puts them at high 
risk as part of their routine medical care.  We do not believe the use of a rotating protocol places them at 
additional risk.  Moreover, clinicians can break the protocol if there is a specific clinical indication without any 
penalty. 
 
      C6.2  Incidental or Unexpected Findings 
 
N/A – This section is not applicable.  Unexpected or incidental findings are not expected as part of this study.  
If, in the unlikely event something is discovered, we will refer the information back to the primary attending 
clinician. 
 
      C6.3  Potential Benefits 
 
The study subjects will experience no direct benefits as a result of participating in this study given that it is 
purely observational .  That said, their participation will facilitate the informing of best intubation practice which 
could conceivably benefit them in the future should they again require emergency airway management.  
 
C7.  DATA AND SAFETY MONITORING 
 
N/A – This section is not applicable. 
 

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C8.  REPORTABLE EVENTS 
 
       C8.1  Expected adverse events 
 
There are a multitude of expected events related to the intubation procedure that are all considered part of 
routine clinical care.  Examples of such events include hypoxia, aspiration, dental or other oral injury, multiple 
intubation attempts, false intubation into the esophagus, injury from the device, infection, and other anatomical 
injuries.  More severely, hypoxic events resulting in anoxic brain injury or peri-intubation cardiac arrest are also 
well-described events associated with intubation and are not expected to be a result of the research study.[11] 
 
       C8.2  Unexpected adverse events and unanticipated problems 
 
We do not anticipate unexpected adverse events as the decision to intubate is purely at the direction of the 
attending clinician.  The devices are already in use in the department and are being used in their FDA cleared 
manner. If an adverse event occurs specific to the research, the adverse event will be reported to the PI or a 
member of the study team.  If the event is determined to be related to the research the PI will follow standard 
reporting procedures for reporting the even to the regulatory office. If in the event there is an unexpected 
adverse event and unanticipated problem, PI or research staff will report to ISR Research Regulatory 
Compliance Division (RRCD) by e-mail to usarmy.jbsa.medcom-aisr.mbx.rcd-human@mail.mil. A complete 
written report will follow the initial notification. 
 
 
       C8.3  Adverse device effects 
 
We do not anticipate adverse events that are specific to this clinical rotating protocol.  As the devices in the 
protocol are already in use in the department, any device related malfunction or risks are similar to that 
associated with the procedure itself. 
 
       C8.4  FDA-regulated research under IND and IDE 
 
N/A – This section is not applicable. 
 
 
 
SECTION D:  REFERENCES 
 
1. 
April, M.D., et al., Emergency Department Intubation Success With Succinylcholine Versus Rocuronium: A 
National Emergency Airway Registry Study. Ann Emerg Med, 2018. 72(6): p. 645-653. 
2. 
April, M.D., et al., A 12-month descriptive analysis of emergency intubations at Brooke Army Medical Center: a 
National Emergency Airway Registry study. US Army Med Dep J, 2017(3-17): p. 98-104. 
3. 
Eastridge, B.J., et al., Died of wounds on the battlefield: causation and implications for improving combat casualty 
care. J Trauma, 2011. 71(1 Suppl): p. S4-8. 
4. 
Eastridge, B.J., et al., Death on the battlefield (2001-2011): implications for the future of combat casualty care. J 
Trauma Acute Care Surg, 2012. 73(6 Suppl 5): p. S431-7. 
5. 
Deakin, C.D., P. King, and F. Thompson, Prehospital advanced airway management by ambulance technicians 
and paramedics: is clinical practice sufficient to maintain skills? Emerg Med J, 2009. 26(12): p. 888-91. 
6. 
Liao, C.C., et al., Video laryngoscopy-assisted tracheal intubation in airway management. Expert Rev Med 
Devices, 2018. 15(4): p. 265-275. 
7. 
Pott, L.M. and W.B. Murray, Review of video laryngoscopy and rigid fiberoptic laryngoscopy. Curr Opin 
Anaesthesiol, 2008. 21(6): p. 750-8. 
8. 
Rai, M.R., A. Dering, and C. Verghese, The Glidescope system: a clinical assessment of performance. 
Anaesthesia, 2005. 60(1): p. 60-4. 
9. 
Serocki, G., et al., Management of the predicted difficult airway: a comparison of conventional blade laryngoscopy 
with video-assisted blade laryngoscopy and the GlideScope. Eur J Anaesthesiol, 2010. 27(1): p. 24-30. 
10. 
Schauer, S.G., et al., A Prospective Assessment of a Novel, Disposable Video Laryngoscope With Physician 
Assistant Trainees Using a Synthetic Cadaver Model. Mil Med, 2020. 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
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11. 
April, M.D., et al., Peri-intubation cardiac arrest in the Emergency Department: A National Emergency Airway 
Registry (NEAR) study. Resuscitation. 
 
 
 
SECTION E:  ABBREVIATIONS AND ACRONYMS 
 
BAMC = Brooke Army Medical Center 
CAC = Common access card 
CRF = Case report form 
DL = Direct laryngoscopy 
HIPAA = Health Insurance portability and accountability act 
ICTL = Individual critical task list 
ICU = Intensive care unit 
IMD = Information Management Division 
MAMC = Madigan Army Medical Center 
PHI = Protected health information 
USAISR = US Army Institute of Surgical Research 
VL = Video laryngoscopy 
 
 
 
SECTION F: DoD PRIVACY RULE AND PROTECTED HEALTH INFORMATION (HIPAA).   
 
 
NA – institution is not a covered entity 
 
 
NA – will not use or disclose protected health information 
 
 
HIPAA authorization will be obtained  
 
X An application for waiver/alteration of HIPAA authorization will be submitted 
 
 

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APPENDIX – Data Collection Variables 
 
Was the patient ALREADY receiving intravenous 
fluid bolus? 
Yes/no 
Estimated volume of fluid bolus infused before meds 
(mL) 
Volume 
Induction/sedation and total doses 
Etomidate 
Ketamine 
Ativan 
Versed 
Morphine 
Fentanyl 
Propofol 
Other (free text) 
None 
Post-intubation sedation 
Etomidate 
Ketamine 
Ativan 
Versed 
Morphine 
Fentanyl 
Propofol 
Other (free text) 
None 
Gender 
Male/female 
Body Mass Index (BMI) 
Numeric 
Self-identified race (from medical record) 
White 
Black/African American 
Asian 
American Indian or Alaska Native 
Native Hawaiian or Other Pacific Islander 
Chronic respiratory comorbidities 
Asthma 
COPD 
Cystic fibrosis 
Interstitial lung disease 
Malignancy 
Neuromuscular weakness 
Obstructive sleep apnea 
Pulmonary hypertension 
Recurrent aspiration 
Other (free text) 
Chronic non-respiratory comorbidities 
Atrial fibrillation 
Cerebrovascular accident 
Chronic kidney disease 
Cirrhosis 
Congestive heart failure 
Coronary artery disease 
Diabetes mellitus 
End-stage renal disease 
Hypertension 
Malignancy, leukemia or lymphoma active 
Solid organ transplant 
stem cell transplant 
Bone marrow transplant 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
HQ USAMRDC IRB Research Protocol Template v_21 SEPTEMBER 2020 
 
Page 7 of 7 
 
Spinal CORD injury 
Traumatic brain injury 
Other (free text) 
Primary admit diagnosis 
Trauma/non-trauma 
Active neurologic conditions at the time of intubation 
Altered mental status 
Intracranial hemorrhage 
Cord compression or epidural abscess 
Meningitis or encephalitis 
Myasthenic crisis 
Seizure or status of left against 
Stroke 
traumatic brain injury 
Active cardiac conditions at the time of intubation 
Cardiac arrest 
Cardiogenic permanent edema 
Congestive heart failure 
Echogenic shock 
Hypertensive urgency or emergency 
Myocardial infarction 
 
Active pulmonary conditions at the time of intubation 
Acute respiratory distress syndrome 
Asthma 
Aspiration 
COPD 
Hypercarbic respiratory failure 
Hypoxemic respiratory failure 
Pneumonia 
Upper airway obstruction 
Active gastrointestinal conditions at the time of 
intubation 
Acute liver failure 
Bowel obstruction 
Bowel perforation 
Gastrointestinal bleeding 
Hepatorenal syndrome 
Pancreatitis 
Prior to intubation, had the patient received ketamine 
or etomidate during this hospitalization (during a 
previous procedure or intubation 
Ketamine 
Etomidate 
Was the patient on corticosteroids at the time of 
enrollment? 
Yes/no 
Vasopressors or inotropes in the hour prior to 
enrollment? 
Yes/no 
Which vasopressor or inotrope? 
Epinephrine 
Norepinephrine 
Phenylephrine 
Dopamine 
Dobutamine  
Milrinone 
Angiotensin II 
Was the patient on BIPAP or HFNC for respiratory 
failure in the 1 hour prior to enrollment (excluding 
pre-oxygenation)? 
Yes/no 
Was the patient on BIPAP or HFNC for respiratory 
failure in the 1 hour prior to enrollment (excluding 
pre-oxygenation)? 
Optiflow, Vapotherm 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
HQ USAMRDC IRB Research Protocol Template v_21 SEPTEMBER 2020 
 
Page 7 of 7 
 
Highest FIO2 delivered in the 1 hour prior to 
enrollment (excluding preoxygenation for the 
procedure). 
For patients on nasal cannula, use estimation that 
FIO2 = 0.21 +  0.03*(LPM of NC O2) 
Neuromuscular Blockers 
Rocuronium 
Vecuronium 
Succinylcholine 
Cisatracurium 
Other 
None 
Unknown 
Total dose of each agent given peri-intubation 
Numeric 
Initial laryngoscope device type 
Free text 
Difficult airway characteristics  (active at the time of 
intubation) 
Vomiting 
Witnessed aspiration 
Upper GI bleeding 
Epistaxis or oral bleeding 
Upper airway mass, infection, trauma 
Head and neck radiation 
Obesity, BMI greater than 30 
Limited neck mobility 
Limited mouth opening 
History of OSA 
Other, free text 
Vital signs at 24 hours 
Systolic blood pressure 
Diastolic blood pressure 
SPO2 
FiO2 
PEEP 
Vasopressors or ionotropes used at 24 hours after 
intubation? 
Epinephrine 
Norepinephrine 
Phenylephrine 
Dopamine 
WB 
Milrinone 
Angiotensin II 
Is a chest x-ray available between intubation and 48 
hours after intubation? 
 
Was a NEW pneumothorax present on the first chest 
x-ray obtained in the first 48 hours after intubation?  
Is there evidence of new pneumonia?  Yes/no 
Cardiac arrest within 1 hour of intubation? 
Yes/no 
Death within 1 hour of intubation? 
Yes/no 
Did the patient die before discharge from the 
hospital? 
 
Yes/no 
Duration of mechanical ventilation (days)? 
Number of days from study intubation until achieved 
achieved final unassisted breathing during this 
hospitalization or death.    Note: After extubation, a 
reintubation for less than 24 hours and for the 
purpose of a procedure will not count as a ventilator 
day.      Information censored at hospital discharge.   
IGNORE data from outpatient records or 
readmissions. 
Did the patient die in the ICU? 
Yes/no 
Duration of mechanical ventilation (days)?     
Numeric 
Duration of vasopressor support (days) 
Numeric 

Protocol Title: A prospective comparison of the disposable i-view versus the durable video laryngoscopes in the emergency department 
Date: 08 March 2021 
 
HQ USAMRDC IRB Research Protocol Template v_21 SEPTEMBER 2020 
 
Page 7 of 7 
 
ICU length of stay (days) 
Numeric