PERCEPTION - Super-Early Neuroprognostication in eCPR Patients

NCT07584187 | Recruiting

• 1 other identifier: 2337/2025
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Resuscitation; ECMO; Extra Corporeal Life Support; Extracorporeal Cardiopulmonary Resuscitation

Keywords

eCPR; ECMO; CPR

Outcome Measures

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.

  Before ECMO initiation.

Secondary Outcomes (4)

• Feasablity of cNIRS

  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

• Neurological Outcome

  1 Month, 6 Months and 12 Months

• Mortality

  1 month, 6 months, and 12 months

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine.

You may qualify if:

• All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Emergency Medicine, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Jürgen Grafeender, MD, PhD

CONTACT

+43 1 40400 19540; juergen.grafeneder@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

AU (1)