PERCEPTION - Super-Early Neuroprognostication in eCPR Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Vienna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Feasability 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.

Secondary outcomes

1

Feasablity of cNIRS

Success rate of obtaining cNIRS measurements in patients being evaluated for eCPR before ECMO initiation

Time frame
before ECMO initiation
2

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
3

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
4

Mortality

Mortality Rate at 1 month, 6 months, and 12 months

Time frame
1 month, 6 months, and 12 months

Other outcomes

Sponsors and contacts

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