Ultrasound to Verify Lung-isolation During Single-lung Ventilation
Phase: NA
Conditions: Thoracic Diseases
Sponsor: Nationwide Children's Hospital

 
Ultrasound to verify lung-isolation during single-lung ventilation 
 
NCT03729999 
 
February 19, 2019 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 1 of 11 
HRP-503  v.12.10.18 
PROTOCOL TITLE: 
Ultrasound to verify lung-isolation during single-lung ventilation 
PRINCIPAL INVESTIGATOR: 
Name: Alok Moharir, MD 
Department/Center: Anesthesiology 
Telephone Number: 614-722-4200 
Email Address: Alok.Moharir@nationwidechildrens.org 
VERSION NUMBER/DATE: 
Version 4/ February 5, 2019 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
4 
2/5/2019 
Increasing the age limit to 21 years. 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 2 of 11 
HRP-503  v.12.10.18 
1.0 
Study Summary 
 
Study Title 
Ultrasound to verify lung-isolation during single-lung 
ventilation 
Study Design 
Prospective study 
Primary Objective 
To determine the accuracy of auscultation and 
ultrasonography for confirming lung isolation during SLV, 
as compared to direct visualization using FOB (gold 
standard). 
Secondary 
Objective(s) 
To compare the time required to confirm lung isolation using 
the above-mentioned techniques including auscultation, 
FOB, and ultrasound. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Ultrasound and auscultation of the chest. 
IND/IDE #  
N/A 
Study Population 
Main OR surgical patients 
Sample Size 
80 
Study Duration for 
individual 
participants 
Less than 30 minutes total. 
Study Specific 
Abbreviations/ 
Definitions  
FOB – Fiberoptic bronchoscope 
SLV – Single-lung ventilation  
DLT – Double-lumen endotracheal tube 
ETT – Endotracheal tube 
 
2.0 
Objectives 
2.1 The primary objective is to determine the accuracy of auscultation 
and ultrasonography for confirming lung isolation during SLV, as 
compared to direct visualization using FOB (gold standard).  The 
secondary objective is to compare the time required to confirm lung 
isolation using the above-mentioned techniques including 
auscultation, FOB, and ultrasound. 
2.2 The hypothesis is that ultrasonography will have at least 80% 
accuracy for verifying lung separation during SLV as confirmed by 
FOB; and will have greater accuracy than auscultation. 
3.0 
Background 
3.1 During thoracic surgery, specific anesthetic techniques are used to 
isolate the lungs and allow for single-lung ventilation (SLV) so that 
the ipsilateral lung is not ventilated during the surgical procedure.1-3 
A motionless lung on the side of surgery is necessary to allow for the 
surgical procedure to proceed optimally.  To accomplish SLV, there 
are several options including use of a specialized double-lumen 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 3 of 11 
HRP-503  v.12.10.18 
endotracheal tube (DLT), placement of a bronchial blocker into the 
main stem bronchus of the operative side, or selective main stem 
intubation with a standard endotracheal tube (ETT).  All of these 
devices allow for selective ventilation of the non-operative lung. In 
common clinical practice, the placement of the device for SLV may 
be guided by direct vision using a fiberoptic bronchoscope (FOB) 
and/or differential auscultation of the two lungs. 
More recently, there has been increased use of ultrasonography at the 
bedside in various clinical locations including the Pediatric ICU and 
the operating room.  Ultrasonography is painless, non-invasive and 
cares no risk.  Given its ease of use and non-invasive nature, 
ultrasound is being used more frequently to make thoracic diagnoses 
including hemothorax, pneumothorax, pneumonia, and ARDS.3-8 
More recently, preliminary data from three studies in adults suggest 
that ultrasound can be used to confirm lung isolation during SLV.9-11  
When the lung is not ventilated, there is no pleural movement noted 
(absence of lung sliding and no B-lines) and as the lung is non-
mobile, the cardiac impulses may be transmitted through the lung to 
the chest wall and can be seen (presence of lung pulse). To date, there 
is only one anecdotal report of the intraoperative use of thoracic 
ultrasonography in the pediatric-aged patient.12 The purpose of the 
current study is to prospectively evaluate the usefulness of thoracic 
ultrasonography is demonstrating effective lung isolation during SLV 
in the pediatric patient. Our primary hypothesis is that ltrasonography 
will accurately verify lung separation during SLV, as compared to 
FOB. 
3.2 This would provide a rapid and non-invasive means to demonstrating 
effective lung isolation without the time, cost, and invasive nature of 
direct visualization using a FOB.  
4.0 
Study Endpoints 
4.1 The accuracy of using ultrasound to assess lung isolation by 
visualizing lung movement or lack thereof of both the operative and 
non-operative lung fields. 
4.2 Time to confirm lung isolation. 
5.0 
Study Intervention/Investigational Agent 
5.1 The only intervention being used that is not normally used in general 
clinical practice is the use of ultrasonography.  The technique is non-
invasive and poses no risk. Ultrasonography will be performed by an 
anesthesiologist with training and experience and will add less than 
10 minutes to the anesthetic time. 
6.0 
Procedures Involved* 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 4 of 11 
HRP-503  v.12.10.18 
6.1 The proposed study will be conducted in 80 patients, ranging in age 
age from 0 to 21 years. There will be no change in clinical practice 
regarding choice of anesthetic technique including premedication, 
device used for SLV, monitoring, induction, and maintenance of 
anesthesia. An investigator will identify patients in whom SLV is 
required for thoracic surgery. There will be total of three anesthesia 
providers and one surgeon involved in the study. One will be the 
primary anesthesiologist, who is one of the attending faculty and will 
be responsible for patient care during the perioperative period. They 
will decide prior to and during the case whether the patient is 
appropriate for and able to complete the study protocol. The other 
two anesthesia providers will be members of the study team or other 
anesthesia attending/fellow and will include an auscultator (may be a 
resident/CRNA/SRNA), the anesthesia provider who will perform 
the auscultation examination and the ultrasonographer, the 
anesthesia provider who will perform the ultrasound examination 
(see below). The surgeon will be the attending surgeon and will 
confirm the efficacy of one-lung ventilation during the surgical 
procedure.  Both the auscultator and ultrasonographer will be 
blinded to the lung that is isolated. 
The technique of SLV will be determined by the attending 
anesthesiology to include a DLT, bronchial blocker or main stem 
intubation with an ETT.  The ventilator settings will be standardized 
until all of the study measurements and data have been collected:  
Ventilation Mode: PRVC 
RR titrated to achieve normocapnia  
Inspiratory time 1 second 
TV set at 6-8 ml/kg 
PEEP: minimum of 5 cm H20 
100% Fi02 
6.2 After anesthetic induction the following ventilatory parameters will 
be recorded: tidal volume, peak inflating pressure, inspiratory time, 
respiratory rate, inspired oxygen concentration, end-tidal carbon 
dioxide, and oxygen saturation. After placement of the device for 
SLV, and isolation of the lung, the non-operative lung will be 
ventilated and the ventilatory parameters will be recorded again. 
Clinical confirmation of effective lung separation will include 
auscultation with documentation of absence of breath sounds on the 
operative side. Following this, correct placement of the DLT will be 
confirmed using FOB. The time to perform FOB will be determined. 
6.3 Once SLV device placement is confirmed by bronchoscopy, the 
patient’s face and airway management devices will be covered by a 
drape to blind to auscultator and ultrasonographer. The auscultator 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 5 of 11 
HRP-503  v.12.10.18 
and ultrasonographer will then enter the room. The auscultator will 
evaluate lung isolation and note the results. The ultrasonographer 
will then evaluate lung isolation with absence of lung sliding and the 
presence of lung pulse on the operative (non-ventilated) lung, and B-
line. The procedure time for each (auscultation and ultrasonography) 
will be determined. Procedure time will be calculated from the time 
that the participant touches the patient to the completion of the 
examination (auscultation or ultrasonography). After the completion 
of the ultrasound examination, the patient will be placed in the 
surgical position. Following this, the surgical procedure will be 
started and lung separation documented by the surgeon. If lung 
separation was not successful, this will be noted.  The intraoperative 
ventilation strategy will be at the discretion of the attending 
anesthesiologist.   
7.0 
Data and Specimen Banking* 
N/A 
 
8.0 
Sharing of Results with Subjects* 
8.1 Results will not be shared 
9.0 
Study Timelines* 
• 
An individual study subject’s participation in the study should last 
approximately 15-30 minutes total.  
• 
All study subjects should be enrolled within 1 year of study start. 
• 
The study should be completed within 2 years of study start.  
10.0 Inclusion and Exclusion Criteria* 
10.1 Potential subjects will be identified by reviewing the surgery 
schedule in Epic and will be recruited from the Surgery Unit pre-op 
area prior to their surgery. 
10.2 Inclusion criteria:  Age 0-21 years, requiring SLV for thoracic 
surgery.   
Exclusion criteria:  None. 
10.3 We are including children, and will not include: 
• 
Adults unable to consent 
• 
Pregnant women 
• 
Prisoners 
11.0 Vulnerable Populations* 
11.1 This study presents no more than minimal risk as it only involves 
ultrasound which is non-invasive, will add less than 10 minutes to 
the total anesthetic time, and written consent is normally not 
required.  

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 6 of 11 
HRP-503  v.12.10.18 
12.0 Local Number of Subjects 
12.1 80 
12.2 Power calculation for this study was based on a previous study 
reporting the accuracy of ultrasonography (compared to FOB) for 
confirming lung isolation when using DLTs.11 This study found the 
accuracy to be 84%-89% depending on which lung was isolated. 
Assuming that ultrasonography has an overall accuracy of 85%, a 
two-tailed, one-sample test of proportions would have >80% power 
to detect a difference of at least 10% when 80 patients are enrolled.  
13.0 Recruitment Methods 
13.1 Subjects will be recruited from the surgery unit pre-op area.  They 
will be identified by reviewing OR schedules in Epic. 
14.0 Withdrawal of Subjects* 
N/A 
 
15.0 Risks to Subjects* 
15.1 Although not likely, there may be a potential risk for breach of 
patient health information. There are no study related physical risks 
to study subjects associated with this study. All study related 
procedures are non-invasive. 
15.2 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
Subject PHI will be stored in a locked cabinet, and will be stored and 
maintained in password protected computer files. 
16.0 Potential Benefits to Subjects* 
16.1 No direct benefit to the subject. 
17.0 Data Management* and Confidentiality 
17.1 We will compare the accuracy, sensitivity, and specificity of 
ultrasonography and auscultation (using FOB confirmation of one-
lung isolation as the reference standard) using paired tests of 
proportions. As a secondary, exploratory aim, we will compare the 
time to perform each of the techniques using paired t-tests or sign-
rank tests (according to the normality of the outcome distribution).  
17.2 Research records will be stored in a locked cabinet and password 
protected computer.  Only certified research personnel will be given 
access to identifiable subject information 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 7 of 11 
HRP-503  v.12.10.18 
17.3 Following publication of study results, research records will be 
stored for a period of 3-5 years and then will be destroyed by placing 
in a secure shredding bin.  
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1 The study will only be monitored by the study investigators. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place limits 
on whom they interact or whom they provide personal information. 
20.0 Compensation for Research-Related Injury 
20.1 None 
21.0 Economic Burden to Subjects 
21.1 None 
22.0 Consent Process 
22.1 We are requesting a waiver of informed consent documentation.  
Subjects will receive a complete explanation of the study and will be 
asked to consent verbally. Subjects will receive a written summary 
of the research as outlined in the attached written Study Information 
Sheet.  Subjects will not be asked to sign a consent form.  
23.0 Process to Document Consent in Writing 
N/A 
24.0 Setting 
24.1 Subjects will be recruited from Surgery Unit and all study 
procedures will take place in the OR after the subject has been 
anesthetized.  
25.0 Resources Available 
25.1 The department of Anesthesiology and Pain Medicine has 2 research 
coordinators and 2 research associates that will be enrolling subjects 
for this study.  All study staff will be trained on the study 
procedures. 
26.0 Multi-Site Research* 
N/A 
 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 8 of 11 
HRP-503  v.12.10.18 
27.0  Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☐  Complete Address 
☐  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☐  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☐  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 
☒  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. 
Other Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 9 of 11 
HRP-503  v.12.10.18 
Following publication of study results, research records will be stored for a period 
of 3-5 years and then will be destroyed by placing in a secure shredding bin. 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. None 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☐ The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
☒ Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy 
interests of subjects, where "privacy interests" refer to the interest of 
individuals in being left alone, limiting access to them, and limiting access to 
their information. (This is not the same provision to maintain the 
confidentiality of data.) 
 
Subject information will not be given to any other investigators. Subjects and 
their information will be closely monitored and guarded by study staff; there will 
be limited access to patients and their information by trained study staff; and 
subject information will only be shared and discussed between study staff specific 
to this study. Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place limits on whom 
they interact or whom they provide personal information. 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☐  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 
☐  Name of treatment provider 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 10 of 11 
HRP-503  v.12.10.18 
☐  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
It is necessary to meet the objectives of the study and to analyze the data. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☐ Yes   ☒ No 
 
References:  
1. 
Tobias JD.  Anesthesia for thoracic surgery in children.  Curr Opin 
Anesthesiol 2001;14:77-85. 
2. 
Golianu B, Hammer GB. Pediatric thoracic anesthesia. Curr Opin 
Anaesthesiol 2005;18:5-11. 
3. 
Hammer GB. Single-lung ventilation in infants and children. Paediatr 
Anaesth 2004;14:98-102. 
4. 
Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit 
Care 2014;20:315-22. 
5. 
Lichtenstein D, van Hooland S, Elbers P, Malbrain ML. Ten good 
reasons to practice ultrasound in critical care. Anaesthesiol Intensive 
Ther 2014;46:323-35. 
6. 
Istasy V, Thompson D, Belisle S, Gharib M, Lim R. The role of point 
of care ultrasound in the injured paediatric patient. Curr Pediatr Rev 
2018;14:41-7. 
7. 
Dominguez A, Gaspar HA, Preto M, Ejzenberg FE. Point-of-care lung 
ultrasound in paediatric critical and emergency care. J Pediatr Child 
Health (in press). 
8. 
Mirabile C, Malekzadeh-Milani S, Vinh TQ, Haydar A. Intraoperative 
hypoxia secondary to pneumothorax: The role of lung ultrasound. 
Paediatr Anaesth 2018;28:468-70. 
9. 
Saporito A, Lo Piccolo A, Franceschini D, Tomasetti R, Anselmi L. 
Thoracic ultrasound confirmation of correct lung exclusion before one-
lung ventilation during thoracic surgery. J Ultrasound 2013;16:195-9. 

PROTOCOL TITLE: Ultrasound to verify lung-isolation during single-lung ventilation 
 
Page 11 of 11 
HRP-503  v.12.10.18 
10. 
Parab SY, Divatia JV, Chogle A. A prospective comparative study to 
evaluate the utility of lung ultrasonography to improve the accuracy of 
traditional clinical methods to confirm position of left sided double 
lumen tube in elective thoracic surgeries. Indian J Anaesth 
2015;59:476-81. 
11. 
Hu WC, Xu L, Zhang Q, Wei L, Zhang W. Point-of-care ultrasound 
versus auscultation in determining the position of double-lumen tube. 
Medicine 2018;97:e9311. 
12. 
Nam JS, Park I, Seo H, Min HG. The use of lung ultrasonography to 
confirm lung isolation in an infant who underwent emergent video-
assisted thoracoscopic surgery - a case report. Korean J Anesthesiol 
2015;68:411-4.