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NCT Number: NCT07526181

Cerebral Oximetry, Pulmonary Artery Catheter Parameters and ECMO 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

  • Cerebral Oximetry

Bilateral frontal sensors, rScO₂ recorded:

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

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

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

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

  • Follow-up data:
  • ECMO duration.
  • Need for oxygen therapy/mechanical ventilation.
  • ICU survival.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Doaa Roshdy Abdul satar, assistant lecturer

CONTACT

[email protected]

2001024588594

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Cairo University/ECMO unit

Registry information

Official study title

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

Acronym: ECMO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 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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