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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07526181
Acronym
ECMO
Enrollment
30
Registered
2026-04-13
Start date
2026-04-20
Completion date
2027-06-30
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Circulatory Support

Keywords

VA-ECMO, NIRS, native COP, ECMO flow

Brief 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.

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER
Cairo University/ECMO unit
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
correlation between native cardiac output/ Extracorporeal membrane oxygenation flow ratio and regional cerebral tissue oxygen saturationfrom date of randomization until the date of ending the ECMO support (assessed up to 100 weeks)

Contacts

CONTACTDoaa Roshdy Abdul satar, assistant lecturer
doaa.elenany@yahoo.com2001024588594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026