Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation (NOTICE)

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation Complication; Cerebral Circulatory Failure
• Intervention / Treatment: Device: VV-ECMO

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Alexander Vlaar, MD PhD MBA; Phone Number: 25846; Email: a.p.vlaar@amsterdamumc.nl
• Study Contact Backup: Name: Rogier Immink, MD PhD; Phone Number: 27182; Email: mailto:r.v.immink@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam-Zuidoost, Netherlands, 1105
    • Recruiting
    • Amsterdam UMC
    • Contact: Alexander Vlaar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Alexander Vlaar, MD PhD MBA, Department of Intensive Care, Amsterdam UMC, location AMC

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: W21_486 # 21.539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No