PERCEPTION - Super-Early Neuroprognostication in eCPR Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated Pupillometry, continuous near-infrared spectroscopy (cNIRS).
- Who it may be relevant to
- Registry conditions: Resuscitation, Extra Corporeal Life Support, ECMO, Extracorporeal Cardiopulmonary Resuscitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Super-Early Neuroprognostication in eCPR Patients: Feasibility of Automated Pupillometry and Cerebral Near-Infrared Spectroscopy - A Prospective Feasibility Study
Overview
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 test Automated Pupillometry
Pupils will be assessed using the NeurOptics® NPi® Pupillometer (NeurOptics, Inc., Irvine, CA) - Diagnostic test continuous 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)
Primary outcome measures
- Feasability of automated pupillometry [Time frame: Before ECMO initiation.]
Secondary outcome measures (4)
- Feasablity of cNIRS [Time frame: before ECMO initiation]
- Rate of acquiring automated pupillometry and cNIRS 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 [Time frame: 1 Month, 6 Months and 12 Months]
- Mortality [Time frame: 1 month, 6 months, and 12 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Department of Emergency Medicine, Medical University of Vienna — Vienna
Identifiers
NCT: NCT07584187 · 2337/2025