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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.
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | No Intervention | ||
| Arm 2: Hamilton C1 ventilator during transport to the ICU | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hamilton C1 ventilator during transport to the ICU | Device | Instead of AMBU bag manual ventilation during transport to the ICU, intervention is using Hamilton C1 ventilator during transport to the ICU |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
Patients who needed to be switched the ventilation method from the originally designated method were excluded from the study before assignment to the arms.
Patient recruitment was done from November 1, 2023, to October 9, 2024. Location was a university medical center. 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU | patients who were transported to the ICU with manual (AMBU bag) ventilation |
| FG001 | Arm 2: Hamilton C1 Ventilator During Transport to the ICU |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 6, 2023 |
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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
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The patients will be randomly assigned to 2 arms above and the patients are not informed about which arm they are assigned.
| 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 (%) | 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) | 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) | 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. |
patients who were transported to the ICU with mechanical (Hamilton C1) ventilation
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU | patients who were transported to the ICU with manual (AMBU bag) ventilation |
| BG001 | Arm 2: Hamilton C1 Ventilator During Transport to the ICU | patients who were transported to the ICU with mechanical (Hamilton C1) ventilation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years old |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Secondary | 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 (%) | Posted | Median | Inter-Quartile Range | The percent change in PF ratio | 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. |
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| Secondary | 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 (%) | Posted | Median | Inter-Quartile Range | The percent change in PaCO2 | 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. |
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| Primary | 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 (%) | Posted | Mean | Standard Deviation | % change in mean artery pressure | 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. |
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| Secondary | 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) | The number of participants who had a change in visual assessment of left ventricular function pre and post-transport | Posted | Count of Participants | Participants | 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. |
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| Secondary | 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) | The number of participants who had a change in visual assessment of right ventricular function pre and post-transport | Posted | Count of Participants | Participants | 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. |
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from enrollment until end of follow-up, up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU | patients who were transported to the ICU with manual (AMBU bag) ventilation | 0 | 38 | 0 | 38 | 0 | 38 |
| EG001 | Arm 2: Hamilton C1 Ventilator During Transport to the ICU | patients who were transported to the ICU with mechanical (Hamilton C1) ventilation | 0 | 39 | 0 | 39 | 0 | 39 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor | Thomas Jefferson University | 2155036472 | moritayoshihisa2016@gmail.com |
| Nov 15, 2025 |
| Prot_SAP_ICF_002.pdf |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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