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

NCT04739007 | Withdrawn

• 1 other identifier: 2020P003054
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Pulmonary Injury

Outcome Measures

Primary Outcomes (1)

• Percent of total distribution of ventilation by region, on given ventilator settings

  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 Outcomes (6)

• Time on VA-ECMO

  14 days, 90 days

• Need to transition to VV-ECMO

  14 days, 90 days

• Time on mechanical ventilation

  14 days, 90 days

• Time in ICU

  14 days, 90 days

• 90-day mortality

  90 days

Interventions

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) PROCEDURE

VA-ECMO used for resuscitation after cardiac arrest

Electrical Impedance Tomography (EIT) DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Heart Arrest; Lung Injury

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reginald Jenney Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 4, 2021
• Study Start: January 9, 2021
• Primary Completion: December 1, 2021
• Study Completion: November 8, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

US (1)