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Clinical Trials/NCT04739007
NCT04739007
Withdrawn
Not Applicable

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

Massachusetts General Hospital1 site in 1 countryJanuary 9, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
Massachusetts General Hospital
Locations
1
Primary Endpoint
Percent of total distribution of ventilation by region, on given ventilator settings
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2021
End Date
November 8, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lorenzo Berra, MD

Reginald Jenney Associate Professor of Anaesthesia

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Time on VA-ECMO(14 days, 90 days)
  • 90-day mortality(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)

Study Sites (1)

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