Recruiting

NCT Number: NCT05303363

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Extracorporeal Membrane Oxygenation Complication Cerebral Circulatory Failure

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam-Zuidoost, 1105, Netherlands

Location status: Recruiting

Location contact

Alexander Vlaar

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vv-ECMO

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.

Primary outcomes

Cerebral Blood Flow (CBF) velocity using Transcranial Doppler Ultrasound (cm/sec)

Time frame: 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.

Change in CBF after correction of extracellular (arterial) pH during ECMO

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Vlaar, MD PhD MBA

CONTACT

[email protected]

25846

Rogier Immink, MD PhD

CONTACT

mailto:[email protected]

27182

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: NOTICE

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Mar 31, 2022
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting