CClinicalTrials.gg
Sign In
Not yet recruitingNCT07526181ECMOUpdated Apr 13, 2026

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

An observational study in Mechanical Circulatory Support, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.
Read the 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.
02

Conditions studied

  • Mechanical Circulatory Support

Keywords

  • VA-ECMO
  • NIRS
  • native COP
  • ECMO flow
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
5 Days
Patient registry
Yes
06

What researchers measure

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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07526181
Lead sponsor
Assiut University
Collaborators
Cairo University/ECMO unit
Responsible party
Doaa Roshdy Abdul Satar Mohamed (Assistant lecturer, Assiut University) — Principal investigator
First posted
Apr 13, 2026
Start date
Apr 20, 2026 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Apr 13, 2026

Study contacts

Doaa Roshdy Abdul satar, assistant lecturer
Contact
doaa.elenany@yahoo.com
2001024588594

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Assiut University

Start the discussion