Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— NOTICE  

Official title:

Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303363
• Other study ID #: W21_486 # 21.539
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: August 15, 2025

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Alexander Vlaar, MD PhD MBA
• Phone: 25846
• Email: a.p.vlaar[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Circulatory Failure
• Extracorporeal Membrane Oxygenation Complication
• Shock

Intervention

Device:
• VV-ECMO
VV-ECMO is indicated in case of severe respiratory failure refractory to other therapies. Indications for VV-ECMO include severe pneumonia, acute respiratory distress syndrome (ARDS) (a.o. due to COVID-19) or near-drowning. ECMO is considered a 'last resort' therapy, in which other maneuvers - such as prone positioning and neuromuscular blockage - have shown to be insufficient. Patients are generally receiving invasive mechanical ventilation and are almost always unconscious, since due to the severe respiratory failure, high doses of sedatives and neuromuscular blockage are often applied to prevent further ventilator-induced damage. After the decision for VV-ECMO is made, the patient is directly cannulated in the ICU or OR following standard protocols.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam-Zuidoost

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

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.