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Enrolling by Invitation

NCT Number: NCT07141524

Optimizing Breathing and Blood Flow in Patients Treated With VA ECMO

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

The investigators hypothesize that an individualized PEEP titration guided by esophageal pressure measurements and Electrical Impedance Tomography can reduce lung overdistention, enhance lung recruitment, and improve V/Q matching by optimizing regional ventilation and perfusion also in VA ECMO.

Our objectives are:

  • To describe V/Q matching in patients undergoing mechanical ventilation during peripheral VA ECMO support.
  • To explore the impact of PEEP titration based on esophageal pressure and EIT in terms of lung mechanics and V/Q matching.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Physiology measurements

Other

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

Primary outcomes

  1. V/Q match

    Time frame: 1 hour

    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).

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Ventilation-Perfusion Matching and PEEP Titration in Patients Undergoing Peripheral Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO)

Acronym: ECMO-VP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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