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

NCT ID: NCT04739007

Last Updated: 2022-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-09

Study Completion Date

2022-11-08

Brief Summary

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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

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Conditions

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Cardiac Arrest Pulmonary Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Veno-arterial extracorporeal membrane oxygenation (VA-ECMO)

VA-ECMO used for resuscitation after cardiac arrest

Intervention Type PROCEDURE

Electrical Impedance Tomography (EIT)

EIT used to demonstrate ventilation and perfusion distribution in intubated patients on VA-ECMO

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lorenzo Berra, MD

Reginald Jenney Associate Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2020P003054

Identifier Type: -

Identifier Source: org_study_id

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