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

Last updated: November 15, 2025
Sponsor: Thomas Jefferson University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Hamilton C1 ventilator during transport to the ICU

Clinical Study ID

NCT06006208
iRISID-2022-1315
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over 18 years old (any gender or race)

  • Cardiac surgery

  • Require postoperative mechanical ventilation and care in the ICU.

Exclusion

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

Total Participants: 78
Treatment Group(s): 1
Primary Treatment: Hamilton C1 ventilator during transport to the ICU
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
April 30, 2025

Study 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 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.

  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

Connect with a study center

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.