PERCEPTION - Super-Early Neuroprognostication in eCPR Patients (PERCEPTION)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Resuscitation; ECMO; Extracorporeal Cardiopulmonary Resuscitation; Extra Corporeal Life Support
• Intervention / Treatment: Diagnostic test: Automated Pupillometry; Diagnostic test: continuous near-infrared spectroscopy (cNIRS)

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Jürgen Grafeender, MD, PhD; Phone Number: +43 1 40400 19540; Email: juergen.grafeneder@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Emergency Medicine, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasablity of cNIRS	Success rate of obtaining cNIRS measurements in patients being evaluated for eCPR before ECMO initiation	before ECMO initiation
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	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
Mortality	Mortality Rate at 1 month, 6 months, and 12 months	1 month, 6 months, and 12 months
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	1 Month, 6 Months and 12 Months

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ECMO; CPR; eCPR
• Other Study ID Numbers: 2337/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No