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.
Study Type
OBSERVATIONAL
Enrollment
45
Pupils will be assessed using the NeurOptics® NPi® Pupillometer (NeurOptics, Inc., Irvine, CA)
Cerebral oxygenation will be measured using the CE-certified continuous near-infrared spectroscopy (cNIRS) with the ForeSight Elite Tissue Oximetry System (Edwards Lifesciences, Switzerland)
Department of Emergency Medicine, Medical University of Vienna
Vienna, Austria
RECRUITINGFeasability of automated pupillometry
The primary outcome is the rate of successful automated pupillometry measurements in patients being evaluated for eCPR before ECMO initiation.
Time frame: Before ECMO initiation.
Feasablity of cNIRS
Success rate of obtaining cNIRS measurements in patients being evaluated for eCPR before ECMO initiation
Time frame: 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
Time frame: 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
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
Time frame: 1 Month, 6 Months and 12 Months
Mortality
Mortality Rate at 1 month, 6 months, and 12 months
Time frame: 1 month, 6 months, and 12 months
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