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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04739007
• Other study ID #: 2020P003054
• Status: Withdrawn
• Start date: January 9, 2021
• Est. completion date: November 8, 2022

Study information

• Verified date: November 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 8, 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Lung Injury
• Pulmonary Injury

Intervention

Procedure:
• Veno-arterial extracorporeal membrane oxygenation (VA-ECMO)
VA-ECMO used for resuscitation after cardiac arrest

Device:
• Electrical Impedance Tomography (EIT)
EIT used to demonstrate ventilation and perfusion distribution in intubated patients on VA-ECMO

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time on VA-ECMO		14 days, 90 days
Secondary	Need to transition to VV-ECMO		14 days, 90 days
Secondary	Time on mechanical ventilation		14 days, 90 days
Secondary	Time in ICU		14 days, 90 days
Secondary	90-day mortality		90 days
Secondary	Incidence of ventilator-associated pneumonia		14 days, 90 days