Cerebral Oximetry, Pulmonary Artery Catheter Parameters and ECMO Flow in Patients Supported With Veno-arterial ECMO (ECMO)

April 10, 2026 updated by: Doaa Roshdy Abdul Satar Mohamed, Assiut University

Cerebral Oximetry in Relation to Pulmonary Artery Catheter Parameters and Extracorporeal Membrane Oxygenation Flow in Patients Supported With Veno-arterial ECMO

for patients connected to VA ECMO due to cardiogenic shock, monitoring:

  1. Cerebral Oximetry
  2. ECMO Parameters ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration

  3. Pulmonary Artery Catheter Data and hemodynamics:

    Cardiac output / cardiac index, SvO₂, Central venous pressure (CVP).

  4. other variables: P/F ratio, MAP, Heart rate, Arterial blood gases, hemoglobin, Lactate, Vasopressor / inotrope doses and Sedation score (RASS).
  5. Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening.

  6. Follow-up data:

    • ECMO duration.
    • Need for oxygen therapy/mechanical ventilation.
    • ICU survival.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

for patients connected to VA ECMO due to cardiogenic shock, monitoring:

  1. Cerebral Oximetry

    Bilateral frontal sensors, rScO₂ recorded:

    at baseline (within 1 hour of ECMO initiation) then every 12 hours.

  2. ECMO Parameters Pump speed (RPM) ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration Arterial cannulation site

  3. Pulmonary Artery Catheter Data and hemodynamics:

    Cardiac output / cardiac index every 12 hours. SvO₂. Central venous pressure (CVP) Mean pulmonary artery pressure. Pulmonary capillary wedge pressure. Systemic vascular resistance.

  4. Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening.

  5. Other variables:

    P/F ratio. MAP. Heart rate. Arterial blood gases. Lactate. Hemoglobin. Vasopressor / inotrope doses. Sedation score (RASS).

  6. Follow-up data:

    • ECMO duration.
    • Need for oxygen therapy/mechanical ventilation.
    • ICU survival.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patient, aged more than 18 years old with cardiogenic shock unresponsive to conventional medical treatment and supported with VA ECMO.

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients supported with veno-arterial ECMO.
  3. Presence of a pulmonary artery catheter.
  4. Expected ECMO support ≥ 24 hours.
  5. Patient with good echocardiographic window.

Exclusion Criteria:

  1. Pre-existing severe neurological injury (e.g. massive stroke, traumatic brain injury).
  2. Intracranial pathology affecting NIRS reliability.
  3. Facial or scalp conditions preventing NIRS probe placement.
  4. ECMO duration < 48 hours.
  5. Poor echocardiographic window.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation between native cardiac output/ Extracorporeal membrane oxygenation flow ratio and regional cerebral tissue oxygen saturation
Time Frame: from date of randomization until the date of ending the ECMO support (assessed up to 100 weeks)
from date of randomization until the date of ending the ECMO support (assessed up to 100 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

Cairo University/ECMO unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIRS, COP & ECMO flow balance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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