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

NCT06006208 | Completed Results DMC FDA Device

• 1 other identifier: iRISID-2022-1315
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ventilator; point of care ultrasound; transport

Outcome Measures

Primary Outcomes (1)

• The % Change in Mean Artery Blood Pressure

  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 (%)

  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.

Secondary Outcomes (4)

• 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 % Change 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 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.

• 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.

Study Arms (2)

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

NO INTERVENTION

Arm 2: Hamilton C1 ventilator during transport to the ICU

EXPERIMENTAL

Device: Hamilton C1 ventilator during transport to the ICU

Interventions

Hamilton C1 ventilator during transport to the ICU DEVICE

Instead of AMBU bag manual ventilation during transport to the ICU, intervention is using Hamilton C1 ventilator during transport to the ICU

Arm 2: Hamilton C1 ventilator during transport to the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Results Point of Contact

• Title: Associate Professor
• Organization: Thomas Jefferson University

moritayoshihisa2016@gmail.com

2155036472

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be randomly assigned to 2 arms above and the patients are not informed about which arm they are assigned.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 23, 2023
• Study Start: November 1, 2023
• Primary Completion: October 9, 2024
• Study Completion: April 30, 2025
• Last Updated: February 3, 2026
• Results First Posted: December 4, 2025

Record last verified: 2026-01

Locations

US (1)