Trial Outcomes & Findings for AMBU Bag Manual Ventilation vs. Transport Ventilator Mechanical Ventilation for Transport (NCT NCT06006208)

Results Overview

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 (%)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

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.

Results posted on

2026-02-03

Participant Flow

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.

Patients who needed to be switched the ventilation method from the originally designated method were excluded from the study before assignment to the arms.

Participant milestones

Participant milestones
Measure	Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU patients who were transported to the ICU with manual (AMBU bag) ventilation	Arm 2: Hamilton C1 Ventilator During Transport to the ICU patients who were transported to the ICU with mechanical (Hamilton C1) ventilation
Overall Study STARTED	39	39
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AMBU Bag Manual Ventilation vs. Transport Ventilator Mechanical Ventilation for Transport

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU n=38 Participants patients who were transported to the ICU with manual (AMBU bag) ventilation	Arm 2: Hamilton C1 Ventilator During Transport to the ICU n=39 Participants patients who were transported to the ICU with mechanical (Hamilton C1) ventilation	Total n=77 Participants Total of all reporting groups
Age, Continuous	61.42 years old STANDARD_DEVIATION 130.8 • n=13 Participants	66.92 years old STANDARD_DEVIATION 8.83 • n=15 Participants	64.2 years old STANDARD_DEVIATION 11.4 • n=28 Participants
Sex: Female, Male Female	13 Participants n=13 Participants	10 Participants n=15 Participants	23 Participants n=28 Participants
Sex: Female, Male Male	25 Participants n=13 Participants	29 Participants n=15 Participants	54 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	2 Participants n=13 Participants	0 Participants n=15 Participants	2 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	7 Participants n=13 Participants	1 Participants n=15 Participants	8 Participants n=28 Participants
Race (NIH/OMB) White	29 Participants n=13 Participants	38 Participants n=15 Participants	67 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants

PRIMARY outcome

Timeframe: 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 (%)

Outcome measures

Outcome measures
Measure	Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU n=38 Participants patients who were transported to the ICU with manual (AMBU bag) ventilation	Arm 2: Hamilton C1 Ventilator During Transport to the ICU n=39 Participants patients who were transported to the ICU with mechanical (Hamilton C1) ventilation
The % Change in Mean Artery Blood Pressure	-3.73 % change in mean artery pressure Standard Deviation 18.04	13 % change in mean artery pressure Standard Deviation 15.61

SECONDARY outcome

Timeframe: 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 % 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 (%)

Outcome measures

Outcome measures
Measure	Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU n=38 Participants patients who were transported to the ICU with manual (AMBU bag) ventilation	Arm 2: Hamilton C1 Ventilator During Transport to the ICU n=39 Participants patients who were transported to the ICU with mechanical (Hamilton C1) ventilation
The % Changes in PaO2/FiO2 (P/F Ratio)	6.76 The percent change in PF ratio Interval -18.61 to 36.26	-12.2 The percent change in PF ratio Interval -38.56 to 17.94

SECONDARY outcome

Timeframe: 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 % 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 (%)

Outcome measures

Outcome measures
Measure	Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU n=38 Participants patients who were transported to the ICU with manual (AMBU bag) ventilation	Arm 2: Hamilton C1 Ventilator During Transport to the ICU n=39 Participants patients who were transported to the ICU with mechanical (Hamilton C1) ventilation
The % Change in PaCO2	3.42 The percent change in PaCO2 Interval -10.0 to 9.08	3.06 The percent change in PaCO2 Interval -8.46 to 11.31

SECONDARY outcome

Timeframe: 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.

Population: The number of participants who had a change in visual assessment of left ventricular function pre and post-transport

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)

Outcome measures

Outcome measures
Measure	Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU n=38 Participants patients who were transported to the ICU with manual (AMBU bag) ventilation	Arm 2: Hamilton C1 Ventilator During Transport to the ICU n=39 Participants patients who were transported to the ICU with mechanical (Hamilton C1) ventilation
The Visual Scale in Changes in Left Ventricular Function	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Population: The number of participants who had a change in visual assessment of right ventricular function pre and post-transport

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)

Outcome measures

Outcome measures
Measure	Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU n=38 Participants patients who were transported to the ICU with manual (AMBU bag) ventilation	Arm 2: Hamilton C1 Ventilator During Transport to the ICU n=39 Participants patients who were transported to the ICU with mechanical (Hamilton C1) ventilation
The Visual Scale in Changes in Right Ventricular Function	0 Participants	0 Participants

Adverse Events

Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Hamilton C1 Ventilator During Transport to the ICU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor

Thomas Jefferson University

Phone: 2155036472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place