Extracorporeal Membrane Oxygenation Complication Clinical Trial
— NOTICEOfficial title:
Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation
Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a supportive therapy, indicated in case of severe, possibly reversible pulmonary failure, refractory to conventional therapies. Despite advances, morbidity and mortality remain high. Severe neurological complications can occur during ECMO, but their exact etiology is not well understood. It is hypothesized that fast correction of severe hypercapnia, a common indication for venovenous ECMO, may be detrimental for the brain. The supposed mechanism is that fast correction of hypercapnia may result in massive cerebral vasoconstriction and impaired cerebral blood flow (CBF). In this prospective, observational study the aim is to quantify change in CBF during routine initial correction of severe hypercapnia during VV-ECMO. Furthermore, the investigators will record any other hemodynamic changes during VV-ECMO. The hypothesis is that a larger decline in PaCO2 will result in a larger decline of CBF.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | August 15, 2025 |
Est. primary completion date | June 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria: - High suspicion of an indication for VV-ECMO; - Arterial line present to enable blood sampling; - Older than 18 years. Exclusion Criteria: - Subjects will be excluded if the cerebral blood flow cannot be measured using the transcranial Doppler - VA-ECMO or ECPR; - No possibility for neuromonitoring measurements due to technical difficulties, e.g. post-craniotomy, unsuitable transcranial window; - No possibility for neuromonitoring measurements due to circumstantial difficulties, e.g. ECPR; - Contraindications for ECMO; - ECMO is initiated in another center. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC | Amsterdam-Zuidoost |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral Blood Flow (CBF) velocity using Transcranial Doppler Ultrasound (cm/sec) | Change in CBF after correction of extracellular (arterial) pH during ECMO | Before,during and after start of VV-ECMO,consisting of:starting 1 hour in advance of ECMO initiation, continuing until a maximum of 1 hour after the last change in SGF. 24 hours after ECMO initiation another measurement of 30 minutes will be performed. |
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