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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04739007
Collaborator
(none)
30
1
13.7
2.2

Study Details

Study Description

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 VV ECMO.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO)
  • Device: Electrical Impedance Tomography (EIT)

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
Actual Study Start Date :
Jan 9, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Time on VA-ECMO [14 days, 90 days]

  2. Need to transition to VV-ECMO [14 days, 90 days]

  3. Time on mechanical ventilation [14 days, 90 days]

  4. Time in ICU [14 days, 90 days]

  5. 90-day mortality [90 days]

  6. Incidence of ventilator-associated pneumonia [14 days, 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02135

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lorenzo Berra, MD, Reginald Jenney Associate Professor of Anaesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04739007
Other Study ID Numbers:
  • 2020P003054
First Posted:
Feb 4, 2021
Last Update Posted:
Feb 4, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2021