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

Thomas Jefferson University

Status: Enrolling

Conditions: Manual Ventilation; Oxygenation; Cardiac Function Disturbance Postoperative; Mechanical Ventilation; Point of Care Ultrasound

Treatments: Device: Hamilton C1 ventilator during transport to the ICU

Study type: Interventional

Funder types: Other

Identifiers

NCT06006208

iRISID-2022-1315

Details and patient eligibility

About

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.

Full 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

Enrollment: 81 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 2 patient groups

Arm 1: AMBU bag manual ventilation during transport to the ICU

No Intervention group

Arm 2: Hamilton C1 ventilator during transport to the ICU

Experimental group

Treatment:

Device: Hamilton C1 ventilator during transport to the ICU