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NCT Number: NCT07584187

PERCEPTION - Super-Early Neuroprognostication in eCPR Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Emergency Medicine, Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

Primary outcomes

  1. Feasability of automated pupillometry

    Time frame: Before ECMO initiation.

    The primary outcome is the rate of successful automated pupillometry measurements in patients being evaluated for eCPR before ECMO initiation.

Secondary outcomes

  1. Feasablity of cNIRS

    Time frame: before ECMO initiation

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

  2. 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

    Rate of acquiring automated pupillometry and cNIRS measurements at predefined subsequent time points following ECMO initiation

  3. Neurological Outcome

    Time frame: 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

  4. Mortality

    Time frame: 1 month, 6 months, and 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jürgen Grafeender, MD, PhD

CONTACT

[email protected]

+43 1 40400 19540

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Super-Early Neuroprognostication in eCPR Patients: Feasibility of Automated Pupillometry and Cerebral Near-Infrared Spectroscopy - A Prospective Feasibility Study

Acronym: PERCEPTION

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 13, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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