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

November 8, 2022 updated by: Lorenzo Berra, MD, Massachusetts General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients without underlying pulmonary disease on VA ECMO post-cardiac arrest

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of total distribution of ventilation by region, on given ventilator settings
Time Frame: 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.
Within 24-48 hours of ECMO cannulation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Actual)

November 8, 2022

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P003054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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