Mechanical Circulatory SupportECMONCT07526181
Cerebral Oximetry, Pulmonary Artery Catheter Parameters and ECMO Flow in Patients Supported With Veno-arterial ECMO
An observational study of Mechanical Circulatory Support, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Circulatory Support
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 30 Jun 2027
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient, aged more than 18 years old with cardiogenic shock unresponsive to conventional medical treatment and supported with VA ECMO.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- Cerebral Oximetry
- ECMO Parameters ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration
- Pulmonary Artery Catheter Data and hemodynamics: Cardiac output / cardiac index, SvO₂, Central venous pressure (CVP).
- other variables: P/F ratio, MAP, Heart rate, Arterial blood gases, hemoglobin, Lactate, Vasopressor / inotrope doses and Sedation score (RASS).
- Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening.
- 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:
- 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.
- Conditions
- Mechanical Circulatory Support
- Keywords
- VA-ECMO, NIRS, native COP, ECMO flow
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between native cardiac output/ Extracorporeal membrane oxygenation flow ratio and regional cerebral tissue oxygen saturation
Measured: from date of randomization until the date of ending the ECMO support (assessed up to 100 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Circulatory SupportStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University/ECMO unit
- Responsible party
- Principal investigator, Doaa Roshdy Abdul Satar Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526181
- Sponsor's protocol ID
- NIRS, COP & ECMO flow balance
- Acronym
- ECMO
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetry in Relation to Pulmonary Artery Catheter Parameters and Extracorporeal Membrane Oxygenation Flow in Patients Supported With Veno-arterial ECMO
- ClinicalTrials.gov ID
- NCT07526181
- Acronym / sponsor ID
- ECMO / NIRS, COP & ECMO flow balance
- Conditions
- Mechanical Circulatory Support
- Keywords
- VA-ECMO, NIRS, native COP, ECMO flow
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Cairo University/ECMO unit
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
for patients connected to VA ECMO due to cardiogenic shock, monitoring:
- Cerebral Oximetry
- ECMO Parameters ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration
- Pulmonary Artery Catheter Data and hemodynamics: Cardiac output / cardiac index, SvO₂, Central venous pressure (CVP).
- other variables: P/F ratio, MAP, Heart rate, Arterial blood gases, hemoglobin, Lactate, Vasopressor / inotrope doses and Sedation score (RASS).
- Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening.
- Follow-up data:
- ECMO duration.
- Need for oxygen therapy/mechanical ventilation.
- ICU survival.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient, aged more than 18 years old with cardiogenic shock unresponsive to conventional medical treatment and supported with VA ECMO.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Circulatory Support, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doaa Roshdy Abdul satar, assistant lecturer (2001024588594, doaa.elenany@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.