Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

High suspicion of an indication for VV-ECMO;

Arterial line present to enable blood sampling;

Older than 18 years.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: VV-ECMO1 intervention

Trial outcomes

Primary outcomes

1

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

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

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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