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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Pupillometry | Diagnostic Test | Pupils will be assessed using the NeurOptics® NPi® Pupillometer (NeurOptics, Inc., Irvine, CA) | ||
| continuous near-infrared spectroscopy (cNIRS) | Diagnostic Test | Cerebral oxygenation will be measured using the CE-certified continuous near-infrared spectroscopy (cNIRS) with the ForeSight Elite Tissue Oximetry System (Edwards Lifesciences, Switzerland) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasability of automated pupillometry | The primary outcome is the rate of successful automated pupillometry measurements in patients being evaluated for eCPR before ECMO initiation. | Before ECMO initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasablity of cNIRS | Success rate of obtaining cNIRS measurements in patients being evaluated for eCPR before ECMO initiation | before ECMO initiation |
| Rate of acquiring automated pupillometry and cNIRS following ECMO initiation |
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Inclusion Criteria:
Exclusion Criteria:
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All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jürgen Grafeender, MD, PhD | Contact | +43 1 40400 19540 | juergen.grafeneder@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Emergency Medicine, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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Rate of acquiring automated pupillometry and cNIRS measurements at predefined subsequent time points following ECMO initiation
| 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 | 1 Month, 6 Months and 12 Months |
| Mortality | Mortality Rate at 1 month, 6 months, and 12 months | 1 month, 6 months, and 12 months |