Cerebral Oximetry, Pulmonary Artery Catheter Parameters and ECMO Flow in Patients Supported With Veno-arterial ECMO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mechanical Circulatory Support. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cerebral Oximetry in Relation to Pulmonary Artery Catheter Parameters and Extracorporeal Membrane Oxygenation Flow in Patients Supported With Veno-arterial ECMO
Overview
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.
Primary outcome measures
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07526181 · NIRS, COP & ECMO flow balance