About this trial
Background Extracorporeal cardiopulmonary resuscitation (eCPR) is a rescue therapy for a selected group of patients. Extracorporeal membrane oxygenation (ECMO) is initiated to bypass the cardiac system and bridge time to definitive treatment of the cardiac arrest (CA) origin. eCPR treatment is very time-critical and, if indicated, should be initiated as early as possible. Patient selection for this highly specific treatment is challenging and relies on numerous factors. In the following phase of intensive care treatment, neuroprognostication is performed. However, following current guidelines, this is only recommended 72hours after CA. Once ECMO is initiated, a complex intensive care treatment is expected, without a guarantee for full neurological recovery. There is a recognized clinical need for more precise selection criteria, alongside predictive values, to enable earlier, reliable neuroprognostication.
Aim This study aims to investigate whether super-early neuroprognostication before ECMO initiation is feasible. Super-early neuroprognostication will be performed using automated pupillometry and cerebral near-infrared spectroscopy (cNIRS) before ECMO initiation.
Methods Patients evaluated for eCPR treatment at the Department of Emergency Medicine will be included in this study. By a study member not involved in clinical treatment, cNIRS and automated pupillometry will be performed before ECMO initiation and at predefined intervals: 10-20 minutes after ECMO Initiation, 1 hour (±15 minutes), 2 hours (±15 minutes), and 3 hours (±15 minutes). Follow-up measurements will be taken 24 hours (± 6 hours), 48 hours (± 6 hours), and 72 hours ± 6 hours after ECMO initiation. The secondary objective is to interpret the collected data regarding outcome parameters.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine
Disqualifiers
Return of spontaneous circulation before ECMO initiation.
Severe facial trauma or deformity preventing the placement of the automated pupillometry device.
Scalp injuries, dressings, or conditions that interfere with the correct positioning of near-infrared spectroscopy (NIRS) sensors.
Pre-existing ocular conditions that preclude reliable pupillometry (e.g., enucleation, opaque cornea, or severe anisocoria unrelated to neurological status).
Trial population
All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine.
Trial design
Cohort
Prospective
Treatments tested in this trial
Automated Pupillometry
Diagnostic testPupils will be assessed using the NeurOptics® NPi® Pupillometer (NeurOptics, Inc., Irvine, CA)
continuous near-infrared spectroscopy (cNIRS)
Diagnostic testCerebral oxygenation will be measured using the CE-certified continuous near-infrared spectroscopy (cNIRS) with the ForeSight Elite Tissue Oximetry System (Edwards Lifesciences, Switzerland)
Treatment groups
Trial outcomes
Primary outcomes
Feasability of automated pupillometry
The primary outcome is the rate of successful automated pupillometry measurements in patients being evaluated for eCPR before ECMO initiation.
Secondary outcomes
Feasablity of cNIRS
Success rate of obtaining cNIRS measurements in patients being evaluated for eCPR before ECMO initiation
Rate of acquiring automated pupillometry and cNIRS following ECMO initiation
Rate of acquiring automated pupillometry and cNIRS measurements at predefined subsequent time points following ECMO initiation
Neurological Outcome
Neurological Outcome at 1 month, 6 months, and 12 months, measured with the Cerebral Performance Category (CPC1-5). CPC 1-2 is considered a good neurological outcome
Mortality
Mortality Rate at 1 month, 6 months, and 12 months
Sponsors and contacts
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