Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When Should we Use a Ventilator?
Phase: NA
Conditions: Oxygenation, Manual Ventilation, Mechanical Ventilation, Point of Care Ultrasound, Cardiac Function Disturbance Postoperative
Sponsor: Thomas Jefferson University

Official study title: Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; 
When Should we Use a Ventilator? 
 
NCT06006208 
 
Date: July 6, 2023 
 
 

PROTOCOL 
Title: Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When 
Should we Use a Ventilator? 
This study was approved by the institutional review board of Thomas Jefferson University 
(iRISID-2023-1921), and verbal informed consent was obtained from all participants before 
enrollment. The trial was registered at ClinicalTrials.gov (NCT06006208) on August 23, 2023 
Study design 
This single-center, prospective clinical trial was conducted at a tertiary academic hospital. 
Study participants  
Patients aged > 18 years who underwent full sternotomy cardiac surgery and required 
postoperative ICU care were included in the study. The exclusion criteria included 
extubation in the operating room, postoperative need for mechanical circulatory support, 
postoperative open chest, and continuous inhalation of epoprostenol or nitric oxide. 
For data analysis population, patients who needed to be switched the ventilation method 
from the originally designated method were excluded. 
Eligible patients were randomized to either (1) manual ventilation using an AMBU bag 
(AMBU, Copenhagen, Denmark) or (2) mechanical ventilation using a Hamilton C1 
ventilator (Hamilton Medical, Reno, NV) during transport to the ICU. Each participant 
provided verbal consent without knowing which arm they were assigned to. The 
anesthesiologist made the final decision regarding the ventilation modality based on the 
post-cardiopulmonary bypass biventricular function and PaO2/FiO2 or PaCO2 levels.  
Primary outcomes  
The primary outcomes included hemodynamic parameters before and after ICU transport. 
Hemodynamic indices mean arterial pressure (MAP). Pre-transport hemodynamic values 
were averaged from the final three readings (taken at 1-min intervals) before switching to 
the transport monitor, and post-transport readings were recorded immediately after 
transfer to the ICU monitor. Significant hypotension was defined as > 20% decrease in MAP 
between pre- and post-transport. The transport time began when the patient was switched 
to manual or mechanical ventilation and ended when the patient was switched to an ICU 
ventilator.  
Secondary outcomes 

The secondary outcomes were the change in PaO2/FiO2 ratio, PaCO2 levels, and 
biventricular function before and after ICU transport. Pre-transport arterial blood gas (ABG) 
samples were obtained when the patient was ready to leave the operating room, and post-
transport ABG samples were collected immediately upon arrival in the ICU. Left ventricular 
(LV) and right ventricular (RV) functions were visually assessed using VScan AIR SL (GE 
Medical, IL) transthoracic echocardiography (TTE) in the apical four-chamber and 
parasternal mid-papillary short-axis views before and after transport. Biventricular function 
was graded as moderate-to-severe hypokinesis (grade 1), mild hypokinesis (grade 2), 
normal (grade 3), or hyperkinesis (grade 4). 
Point-of-care ultrasound (POCUS) training 
Cardiac anesthesiologists received on-site training from a GE Healthcare representative on 
the assessment of biventricular function using the VScan Air ultrasound device. 
Anesthesia and ventilation protocols 
General anesthesia was induced via endotracheal intubation, and arterial, central venous, 
and pulmonary arterial lines were placed alongside the transesophageal 
echocardiography. The selection of anesthetic agents, inotropes, vasopressors, transfusion 
strategies, and fluid management was at the discretion of the attending anesthesiologist. 
Dexmedetomidine 0.7–1.0 mcg/kg/h was used for sedation during the transport to the ICU. 
For manual ventilation, the AMBU bag technique, including the PEEP valve setting (5–10 
cmH2O), was performed by each anesthesiologist. For mechanical ventilation using the 
Hamilton C1 ventilator, the respiratory therapist configured the ventilator to deliver a tidal 
volume and respiratory rate consistent with the final operating room settings (tidal volume: 
6–8 mL/ideal body weight [kg], respiratory rate: 14–16 breaths/min, PEEP: 5–10 cmH2O, 
and FiO2:100%). Airway pressure and end-tidal CO2 levels were not monitored during 
transport. 
Sample size determination and statistical analysis  
Sample size calculations were based on prior clinical experience and data from a previous 
study.3 We hypothesized that 0% of patients receiving mechanical ventilation would 
experience a decrease in MAP during transport compared with 28% of those manually 
ventilated with an AMBU bag. With an alpha level of 0.05 and 90% power, we estimated that 
38 patients per group (N = 76) would be required.  
Summary statistics are presented for the demographic and clinical variables in each group. 
Continuous variables are expressed as mean ± standard deviation (SD) or median 
(interquartile range [IQR]), as appropriate. Categorical data are summarized as frequencies 

and percentages. Group comparisons were performed using the independent t-test or 
Mann–Whitney U test for continuous variables. Correlations between two continuous 
variables were assessed using Pearson’s or Spearman’s rank correlation test. Receiver 
operating characteristic (ROC) curve analysis was used to assess the accuracy of the 
predictive value of SVR for > 20% drop in MAP. Statistical significance was set at p < 0.05. 
All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical 
University, Saitama, Japan), a graphical user interface for R (R Foundation for Statistical 
Computing, Vienna, Austria). More precisely, this is a modified version of R 
commander designed to add statistical functions that are frequently used in biostatistics. 

PI:  Yoshi Morita, MD
IRB Control #iRISID-2022-1315
Sponsor:  Department of anesthesiology
Abbreviated Title:  AMBU v Hamilton
Version Date:  MM/DD/YYYY
Version Number:  X.X
Page 1 of 5
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Jefferson Office of Human Research
Verbal Consent with Optional Use of Disclosure of PHI 
OHR-8H
Version Date – FOR OHR USE: 1/20/20
Department: Anesthesiology
Principal Investigator: Yoshihisa Morita
Study Title: Ventilation during intensive care unit transport after cardiac surgeries; when 
should we use a ventilator?
Lay Title: AMBU bag manual ventilation vs. transport ventilator mechanical 
ventilation for transporting cardiac patients
Hello, my name is __________.  I’m from Jefferson’s Department of Anesthesia, 
cardiac anesthesia division.
I am contacting you because I obtained your contact information from your 
surgeon’s surgery schedule.
We are conducting a research study that consists of asking you questions 
about your past medical history and scheduled surgery and assessing your 
oxygenation and ventilation during transport to the ICU (Intensive Care Unit) 
after your heart surgery. This will take about 10 minutes to complete. About 
51 people will take part in this research at Jefferson and about 51 in the whole 
study. 
The purpose of this research is to compare the use of manual ventilation to 
mechanical ventilation to support your breathing while you are being 
transferred to the ICU after your heart surgery.  After cardiac surgery, unless 
the endotracheal tube (breathing tube) is removed in the operating room (OR), 
patients remain intubated and breathing is supported manually or 
mechanically, with a ventilator, depending on the situation. The decision on 
ventilatory method is based on patients' health factors, surgical factors, and 
surgeon preference, but mostly made based on your anesthesiologist and/ or 
surgeons previous experience during this critical time, due to lack of clinical 
research evidence. . We are planning to explore this concept in real situations 
and gather more clinical data to support more evidence based decisions.  Both 
manual and mechanical ventilation are standard of care. You will be randomly 
assigned to manual ventilation or mechanical ventilation, but mechanical 
ventilation will be chosen if it is medically indicated during the surgery  The 
decision will be made by your anesthesia provider based on your respiratory 
Thomas Jefferson University (OHR)
IRB NUMBER: iRISID-2023-1921
IRB APPROVAL DATE: 07/06/2023

PI:  Yoshi Morita, MD
IRB Control #iRISID-2022-1315
Sponsor:  Department of anesthesiology
Abbreviated Title:  AMBU v Hamilton
Version Date:  MM/DD/YYYY
Version Number:  X.X
Page 2 of 5
2
status after cardiopulmonary bypass, before you are transported to the ICU 
following surgery. 
The alternative to being in this study is to not take part. Your participation is 
voluntary. It is your choice whether or not you want to take part. If you choose 
not to take part or choose to stop taking part at any time, there will be no 
penalty or loss of benefits that you would normally get.
You may or may not personally benefit from taking part in this research. Some 
of the possible benefits may be availability of more detailed clinical data (such 
as heart function assessment with echocardiography before and after 
transport) which may lead to proactive interventions, if needed, to provide a 
better outcome for you or patients in the future.
A risk of taking part in this study is that you may not feel comfortable 
answering some of the questions. If any question makes you feel 
uncomfortable, you do not have to answer the question.
The other possible risk is a loss of the confidentiality of your information. Your 
information will be de-identified for data analysis. Information will be collected 
about you for this study. The information will be seen by the people involved 
with this research. Steps will be taken to protect your identity. But the 
information collected about you can never be 100% secure.
The other possible risks are that a ventilator machine or manual ventilation 
can be dysfunctional or accidentally disconnected from the breathing circuits. 
These risks are very unlikely given that our devices are routinely maintained 
by our BioMedical technicians and manual ventilation will always be available. 
Manual ventilation will be done with a new AMBU bag for each patient.
There will be no cost to you for taking part in this study. You will not be paid 
for taking part in this study. If this research or the information you provide 
results in commercial profit, you will not receive any money.
HIPAA (Health Insurance Portability and Accountability Act) – This is the law 
that protects your personal health information.
To do this study, we need to collect, use, and share your personal health 
information. I will explain why your information is being collected, what 
information will be collected, and who will have access to it. By agreeing, you 
are giving us permission to use your information as described in this form.
We are committed to respecting your privacy and to keeping your personal 
health information confidential. Your personal health information includes the 
Thomas Jefferson University (OHR)
IRB NUMBER: iRISID-2023-1921
IRB APPROVAL DATE: 07/06/2023

PI:  Yoshi Morita, MD
IRB Control #iRISID-2022-1315
Sponsor:  Department of anesthesiology
Abbreviated Title:  AMBU v Hamilton
Version Date:  MM/DD/YYYY
Version Number:  X.X
Page 3 of 5
3
information in your health care records and information that can identify you. 
For example, personal information may include your name, address, phone 
number, social security number, and medical information. The personal health 
information that may be collected, used, and shared for this research includes:

Information from your medical records, Demographic information such 
as name, gender, birth date, ethnicity (required if research is federally-
funded), 
medical 
history, 
and 
health 
care 
providers, 
Physical 
examinations, procedures, tests, labs, your medical conditions, and 
medications you use, Information collected about any research related 
injury.
Your personal information will be used by and shared with the following:

Personnel at Thomas Jefferson University and its affiliates for the 
purpose of this research

Institutional Review Board (ethics committee that reviews research) 
including Thomas Jefferson University IRB

Health insurance providers

Others as required by law
When your personal information is provided to some of the people listed, it 
may no longer be protected under the HIPAA privacy law. You can see your 
health care records at any time. However, generally you will not be able to see 
your study records or the study results until the study is completed.  A copy of 
this signed form, information about this study, and the results of any study 
test or procedure may be included in your health records which may be seen 
by your insurance company and your health care providers.  
This authorization does not have an expiration date. If you want to end your 
permission to collect your information, please inform the investigator in 
writing. If you do this, no more information will be collected, but the 
information already collected will still be used. If you end your permission to 
use your personal information, you will not be able to continue in this study.
The information from this study may be published in scientific journals or 
presented at scientific meetings, but you will not be personally identified.
Your private information and specimens, with the identifiers removed, could 
be used for future research studies or distributed to other researchers for 
future research studies without your additional permission. 
_____________________________________________________________________________
Thomas Jefferson University (OHR)
IRB NUMBER: iRISID-2023-1921
IRB APPROVAL DATE: 07/06/2023

PI:  Yoshi Morita, MD
IRB Control #iRISID-2022-1315
Sponsor:  Department of anesthesiology
Abbreviated Title:  AMBU v Hamilton
Version Date:  MM/DD/YYYY
Version Number:  X.X
Page 4 of 5
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Do you agree to participate in this research study as it has been described to 
you?
If you have any questions about this research, you can contact:
Name: 
Yoshihisa 
Morita, 
Phone 
Number: 
215-955-6161, 
Email: 
Yoshihisa.morita@jefferson.edu
If you need to contact someone other than the study personnel about a 
concern or your rights as a research subject, please call the Jefferson IRB at: 
215-503-0203, 215-503-8966, or 215-955-4239.
Investigator writes name of participant and signs to verify verbal 
response of subject:
Name 
of 
research 
participant 
_____________________________________________________
  YES, the participant consented
  NO, the participant did NOT 
consent
______________________    
______________________    
__________
Name of Investigator
Signature of Investigator 
 
       
Date
Following the verbal consent procedure, the research subject must be 
provided with a separate letter or information card that clearly identifies a 
contact person within the department. If the researcher does not already have 
the subject’s address, then this information must be collected during the 
phone interview. The letter or information card must be part of the first written 
communications to the subject. The letter or information card must include 
the following:
Thomas Jefferson University (OHR)
IRB NUMBER: iRISID-2023-1921
IRB APPROVAL DATE: 07/06/2023

PI:  Yoshi Morita, MD
IRB Control #iRISID-2022-1315
Sponsor:  Department of anesthesiology
Abbreviated Title:  AMBU v Hamilton
Version Date:  MM/DD/YYYY
Version Number:  X.X
Page 5 of 5
5
Thank you for participating in our research study.  If you have additional 
questions or concerns, please contact:
1. Contact person name and title: 
Yoshihisa Morita, MD Department/Division address:
Cardiac anesthesia. 
Thomas Jefferson University Hospital. 
111 South 11th street, Suite 8130V Gibbon Bldg
Philadelphia, PA 19107-4824
Department/Division telephone and FAX numbers: 215-503-6476 (P), 215-955-
0677 (F)
2. If you need to contact someone other than the study personnel about a 
concern or your rights as a research subject, please call the Jefferson IRB 
at: 215-503-0203, 215-503-8966, or 215-955-4239.
Thomas Jefferson University (OHR)
IRB NUMBER: iRISID-2023-1921
IRB APPROVAL DATE: 07/06/2023