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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04739007
Enrollment
0
Registered
2021-02-04
Start date
2021-01-09
Completion date
2022-11-08
Last updated
2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Pulmonary Injury

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.

Interventions

PROCEDUREVeno-arterial extracorporeal membrane oxygenation (VA-ECMO)

VA-ECMO used for resuscitation after cardiac arrest

DEVICEElectrical Impedance Tomography (EIT)

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Percent of total distribution of ventilation by region, on given ventilator settingsWithin 24-48 hours of ECMO cannulationEIT 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

MeasureTime frame
Need to transition to VV-ECMO14 days, 90 days
Time on mechanical ventilation14 days, 90 days
Time on VA-ECMO14 days, 90 days
90-day mortality90 days
Incidence of ventilator-associated pneumonia14 days, 90 days
Time in ICU14 days, 90 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026