Resuscitation, Extra Corporeal Life Support, ECMO, Extracorporeal Cardiopulmonary Resuscitation
Conditions
Keywords
eCPR, ECMO, CPR
Brief summary
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.
Interventions
DIAGNOSTIC_TESTAutomated Pupillometry
Pupils will be assessed using the NeurOptics® NPi® Pupillometer (NeurOptics, Inc., Irvine, CA)
DIAGNOSTIC_TESTcontinuous near-infrared spectroscopy (cNIRS)
Cerebral oxygenation will be measured using the CE-certified continuous near-infrared spectroscopy (cNIRS) with the ForeSight Elite Tissue Oximetry System (Edwards Lifesciences, Switzerland)
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine
Exclusion criteria
* Return of spontaneous circulation before ECMO initiation. * Anatomical infeasibility for measurement, including but not limited to: * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasability of automated pupillometry | Before ECMO initiation. | The primary outcome is the rate of successful automated pupillometry measurements in patients being evaluated for eCPR before ECMO initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasablity of cNIRS | before ECMO initiation | 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 | 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 | Rate of acquiring automated pupillometry and cNIRS measurements at predefined subsequent time points following ECMO initiation |
| Neurological Outcome | 1 Month, 6 Months and 12 Months | 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 | 1 month, 6 months, and 12 months | Mortality Rate at 1 month, 6 months, and 12 months |
Countries
Austria
Contacts
CONTACTJürgen Grafeender, MD, PhD
Outcome results
None listed