Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)

Withdrawn

• Conditions: Cardiac Arrest; Pulmonary Injury

• Registration Number: NCT04739007
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. In this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on VA ECMO. The specific aims of this study are as follows:

Aim 1: To characterize the lung ventilation strategy employed in patients on VA ECMO and its success.

Aim 2: To characterize respiratory system mechanics while on ECMO using esophageal manometry and Electrical Impedance Tomography (EIT).

Aim 3: To characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy.

The overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. Therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ECMO.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-09
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-04
• Primary Completion: 2021-12
• Status Verified: 2022-11
• Study Completion: 2022-11-08
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• On VA ECMO after cardiac arrest
• Between 18 and 85 years of age
• Has an orogastric or nasogastric tube with esophageal balloon capabilities in place

Exclusion Criteria

• Known pre-existing significant pulmonary pathology
• Pacemaker or implanted cardiac defibrillator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of total distribution of ventilation by region, on given ventilator settings	Within 24-48 hours of ECMO cannulation	EIT will be used to determine the percent of total ventilation occurring in each of four lung quadrants on an axial plane: right upper, left upper, right lower, and left lower.

Secondary Outcome Measures

Name	Time	Method
90-day mortality	90 days
Time on VA-ECMO	14 days, 90 days
Time on mechanical ventilation	14 days, 90 days
Need to transition to VV-ECMO	14 days, 90 days
Time in ICU	14 days, 90 days
Incidence of ventilator-associated pneumonia	14 days, 90 days

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States