Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation

NCT ID: NCT05303363

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2025-08-15

Brief 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.

Conditions

Extracorporeal Membrane Oxygenation Complication; Cerebral Circulatory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

VV-ECMO

Critically ill patients with a suspected indication for VV-ECMO. ECMO will be provided according to local guidelines. In the Amsterdam UMC, location AMC, next to VV-ECMO, veno-arterial (VA-ECMO) is also provided. For this study, only patients on VV-ECMO will be included.

VV-ECMO

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

A.P.J. Vlaar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Vlaar, MD PhD MBA

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care, Amsterdam UMC, location AMC

Locations

Amsterdam UMC

Amsterdam-Zuidoost, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Alexander Vlaar, MD PhD MBA

Role: CONTACT

a.p.vlaar@amsterdamumc.nl

25846

Rogier Immink, MD PhD

Role: CONTACT

mailto:r.v.immink@amsterdamumc.nl

27182

Facility Contacts

Alexander Vlaar

Role: primary

Other Identifiers

W21_486 # 21.539

Identifier Type: -

Identifier Source: org_study_id