Optimizing Breathing and Blood Flow in Patients Treated With VA ECMO

NCT07141524 | Enrolling By Invitation

• 1 other identifier: 2025P000675
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to characterize ventilation/perfusion (V/Q) matching in adult patients receiving peripheral VA ECMO support while on mechanical ventilation, and to evaluate the impact of PEEP titration guided by Electrical Impedance Tomography (EIT) and esophageal pressure measurements on lung mechanics and V/Q optimization.

Conditions

VA-ECMO

Keywords

Ventilation / perfusion; ECMO; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• V/Q match

  Primary outcome measure: Reduction in shunt fraction (expressed in %) Secondary outcome measure: Reduction in dead space (expressed as volume) Respiratory mechanics will be recorded before and after best PEEP. Ventilation (L/min)/Perfusion (L/min) \[V/Q\] ratio comparing baseline with best PEEP (after PEEP optimization trial).

  1 hour

Study Arms (1)

Lung physiology assessment

OTHER

Measurement of lung perfusion (via EIT) and transpulmonary pressure (via esophageal manometry) during decremental PEEP trial

Other: Physiology measurements

Interventions

Physiology measurements OTHER

Measurement of lung perfusion (via EIT) and transpulmonary pressure (via esophageal manometry) during decremental PEEP trial

Lung physiology assessment

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years) undergoing mechanical ventilation during peripheral VA ECMO support for cardiogenic shock, cardiac arrest, or refractory heart failure.
• On ECMO support for at least 6 hours
• Swan-Ganz catheter required as standard clinical care
• Clinically stable in the estimation of the study investigator

You may not qualify if:

• Contraindications to EIT (e.g., presence of pacemaker or IMPELLA device for electrical interference)
• Patients without pulmonary flow (non-pulsatile pulmonary prSessure)
• Patients with known pulmonary embolism
• Imminent withdrawal of life support

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-10

Locations

US (2)