Clinical trial NCT06006208: AMBU Bag Manual Ventilation Vs. Transport Ventilator Mechanical Ventilation for Transport
Official title: Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When Should We Use a Ventilator?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oxygenation
Manual Ventilation
Mechanical Ventilation
Point of Care Ultrasound
Cardiac Function Disturbance Postoperative
Keywords: ventilator
point of care ultrasound
transport
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: The visual scale in changes in left ventricular function
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.
measure: The visual scale in changes in right ventricular function
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.
Secondary outcomes:
measure: The changes in PaO2/FiO2 (P/F ratio)
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.
measure: The changes in PaCO2
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.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: