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

Not Applicable

Recruiting

• Conditions: Oxygenation; Manual Ventilation; Point of Care Ultrasound; Cardiac Function Disturbance Postoperative; Mechanical Ventilation
• Interventions: Device: Hamilton C1 ventilator during transport to the ICU

• Registration Number: NCT06006208
• Lead Sponsor: Thomas Jefferson University

Brief 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.

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.

1. To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function, and hemodynamics (including blood pressure, heart rate, pulmonary artery pressure and central venous 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, hemodynamics, 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.

2. 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 Timeline

• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-23
• Study Start: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Over 18 years old (any gender or race)
• Cardiac surgery
• Require postoperative mechanical ventilation and care in the ICU.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Hamilton C1 ventilator during transport to the ICU	Hamilton C1 ventilator during transport to the ICU	-

Primary Outcome Measures

Name	Time	Method
The visual scale in changes in right ventricular function	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.	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 visual scale in changes in left ventricular function	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.	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)

Secondary Outcome Measures

Name	Time	Method
The changes 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.	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.
The changes in PaO2/FiO2 (P/F 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.	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.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States