OxygenationNCT06006208
AMBU Bag Manual Ventilation vs. Transport Ventilator Mechanical Ventilation for Transport
A study testing Hamilton C1 ventilator during transport to the ICU in people with Oxygenation and Manual Ventilation, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygenation, Manual Ventilation, Mechanical Ventilation
- What is being tested?
- Hamilton C1 ventilator during transport to the ICU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old (any gender or race)
- Cardiac surgery
- Require postoperative mechanical ventilation and care in the ICU.
Who cannot join
- Patients' refusal
- Extubation in OR
- On mechanical circulatory support
- Requirement for postoperative therapy with inhaled pulmonary vasodilators (epoprostenol (FLOLAN), inhaled nitric oxide, etc.)
- Severe RV dysfunction with preoperative echocardiography
- Contraindication to TEE and pulmonary artery catheter.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When Should we Use a Ventilator?
This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.
Read the detailed description
Following cardiac surgery, patients often require ventilation during transport to the intensive care unit (ICU). Most of the time, manual ventilation using an AMBU bag (AMBU INC. MD, USA) is utilized, but some patients need mechanical ventilation due to concern for oxygenation, ventilation, and hemodynamics. The indication to choose mechanical ventilation over manual ventilation is determined on a case-by-case basis, mostly based on providers' experiences or surgical request, because currently there is no clear clinical evidence behind that. With this clinical study, the investigators intend to build up clinical evidence by comparing oxygenation, ventilation, hemodynamics, and cardiac functions between two arms: manual ventilation using AMBU bag arm and mechanical ventilation using a transport ventilator.
Objective: In this study, the investigators plan to compare the effects of transport ventilators (Hamilton C1: Bodaduz, Schweiz) and AMBU bag manual ventilation on oxygenation, ventilation, biventricular function, and hemodynamics. This is a two-arm study.
- To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function, and mean artery pressure in the AMBU bag and Hamilton transport ventilator groups. The investigators hypothesize that using the Hamilton transport ventilator will show a smaller change in P/F ratio, mean artery blood pressures and biventricular function compared to the AMBU bag group. If true, these findings would support using the Hamilton ventilator for transport in appropriate surgical patients.
- To perform "in-vitro" flow analysis using a flow analyzer analyzer (CITREX H5:
Buchs, Schweiz) and lung simulator (SmartLung 2000: Buchs, Schweiz) to measure the accuracy of the ventilations of Hamilton C1 ventilator and AMBU bag manual ventilation on different resistance and compliance settings of the lung simulator
- Conditions
- Oxygenation, Manual Ventilation, Mechanical Ventilation, Point of Care Ultrasound, Cardiac Function Disturbance Postoperative
- Being tested
- Hamilton C1 ventilator during transport to the ICU
- Keywords
- ventilator, point of care ultrasound, transport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamilton C1 ventilator during transport to the ICUDevice
Instead of AMBU bag manual ventilation during transport to the ICU, intervention is using Hamilton C1 ventilator during transport to the ICU
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | No intervention | Not described |
| Arm 2: Hamilton C1 ventilator during transport to the ICU | Experimental | Not described Receives: Device: Hamilton C1 ventilator during transport to the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
The % Change in Mean Artery Blood Pressure
The % change in mean artery blood pressure before and after the transport to the ICU.
i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
Measured: 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.
Secondary outcomes (4)
The % Changes in PaO2/FiO2 (P/F Ratio)
The % changes in PaO2/FiO2 (P/F ratio) pre and post transport to ICU. P/F ratio will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above.
i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
Measured: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
The % Change in PaCO2
The % changes in PaCO2 pre and post transport to ICU. PaCO2 will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above.
i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
Measured: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
The Visual Scale in Changes in Left Ventricular Function
Within-group and between-group changes in visual assessment of left ventricular function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)
Measured: First visual assessment of left ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
The Visual Scale in Changes in Right Ventricular Function
Within-group and between-group changes in visual assessment of right ventricular cardiac function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)
Measured: First visual assessment of right ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Nov 2023
- Primary completion9 Oct 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After IRB approval and obtaining a written informed consent, patients will be randomly assigned to the one of the following 2 arms. However, AMBU bag arm patients may be switched to Hamilton C1 at an anesthesia provider's discretion based on post cardiopulmonary bypass right ventricular function, PaO2/FiO2, and PaCO2. These patients will be excluded from the AMBU bag arm. Arm 1: AMBU bag manual ventilation during transport to the ICU Arm 2: Hamilton C1 ventilator during transport to the ICU
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihisa Morita, MD, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006208
- Sponsor's protocol ID
- iRISID-2022-1315
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2023
- Last updated
- 3 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When Should we Use a Ventilator?
- ClinicalTrials.gov ID
- NCT06006208
- Acronym / sponsor ID
- iRISID-2022-1315
- Conditions
- Oxygenation, Manual Ventilation, Mechanical Ventilation, Point of Care Ultrasound, Cardiac Function Disturbance Postoperative
- Keywords
- ventilator, point of care ultrasound, transport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Posted 4 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.
Detailed description
Following cardiac surgery, patients often require ventilation during transport to the intensive care unit (ICU). Most of the time, manual ventilation using an AMBU bag (AMBU INC. MD, USA) is utilized, but some patients need mechanical ventilation due to concern for oxygenation, ventilation, and hemodynamics. The indication to choose mechanical ventilation over manual ventilation is determined on a case-by-case basis, mostly based on providers' experiences or surgical request, because currently there is no clear clinical evidence behind that. With this clinical study, the investigators intend to build up clinical evidence by comparing oxygenation, ventilation, hemodynamics, and cardiac functions between two arms: manual ventilation using AMBU bag arm and mechanical ventilation using a transport ventilator.
Objective: In this study, the investigators plan to compare the effects of transport ventilators (Hamilton C1: Bodaduz, Schweiz) and AMBU bag manual ventilation on oxygenation, ventilation, biventricular function, and hemodynamics. This is a two-arm study.
- To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function, and mean artery pressure in the AMBU bag and Hamilton transport ventilator groups. The investigators hypothesize that using the Hamilton transport ventilator will show a smaller change in P/F ratio, mean artery blood pressures and biventricular function compared to the AMBU bag group. If true, these findings would support using the Hamilton ventilator for transport in appropriate surgical patients.
- To perform "in-vitro" flow analysis using a flow analyzer analyzer (CITREX H5:
Buchs, Schweiz) and lung simulator (SmartLung 2000: Buchs, Schweiz) to measure the accuracy of the ventilations of Hamilton C1 ventilator and AMBU bag manual ventilation on different resistance and compliance settings of the lung simulator
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After IRB approval and obtaining a written informed consent, patients will be randomly assigned to the one of the following 2 arms. However, AMBU bag arm patients may be switched to Hamilton C1 at an anesthesia provider's discretion based on post cardiopulmonary bypass right ventricular function, PaO2/FiO2, and PaCO2. These patients will be excluded from the AMBU bag arm. Arm 1: AMBU bag manual ventilation during transport to the ICU Arm 2: Hamilton C1 ventilator during transport to the ICU
| Arm | Type | Receives |
|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | No intervention | – |
| Arm 2: Hamilton C1 ventilator during transport to the ICU | Experimental | Device: Hamilton C1 ventilator during transport to the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old (any gender or race)
- Cardiac surgery
- Require postoperative mechanical ventilation and care in the ICU.
Key exclusion criteria (6 listed)
- Patients' refusal
- Extubation in OR
- On mechanical circulatory support
- Requirement for postoperative therapy with inhaled pulmonary vasodilators (epoprostenol (FLOLAN), inhaled nitric oxide, etc.)
- Severe RV dysfunction with preoperative echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamilton C1 ventilator during transport to the ICUInstead of AMBU bag manual ventilation during transport to the ICU, intervention is using Hamilton C1 ventilator during transport to the ICU | Device | Arm 2: Hamilton C1 ventilator during transport to the ICU |
Primary outcome
The % Change in Mean Artery Blood Pressure
Time frame: 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.
The % change in mean artery blood pressure before and after the transport to the ICU. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
4 secondary outcomes
The % Changes in PaO2/FiO2 (P/F Ratio)
Time frame: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
The % Change in PaCO2
Time frame: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
The Visual Scale in Changes in Left Ventricular Function
Time frame: First visual assessment of left ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
The Visual Scale in Changes in Right Ventricular Function
Time frame: First visual assessment of right ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamilton C1 ventilator during transport to the ICU in people with Oxygenation and Manual Ventilation, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The % Change in Mean Artery Blood Pressure (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.