ResuscitationPERCEPTIONNCT07584187
PERCEPTION - Super-Early Neuroprognostication in eCPR Patients
An observational study of Resuscitation and Extra Corporeal Life Support, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resuscitation, Extra Corporeal Life Support, ECMO
- What is being tested?
- Automated Pupillometry and continuous near-infrared spectroscopy (cNIRS)
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 12 May 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine.
Who may be able to join
- All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Emergency Medicine, Medical University of Vienna
Vienna, 1090
About this study
Official title: 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.
- Conditions
- Resuscitation, Extra Corporeal Life Support, ECMO, Extracorporeal Cardiopulmonary Resuscitation
- Being tested
- Automated Pupillometry, continuous near-infrared spectroscopy (cNIRS)
- Keywords
- eCPR, ECMO, CPR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated PupillometryDiagnostic 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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability of automated pupillometry
The primary outcome is the rate of successful automated pupillometry measurements in patients being evaluated for eCPR before ECMO initiation.
Measured: Before ECMO initiation.
Secondary outcomes (4)
Feasablity of cNIRS
Success rate of obtaining cNIRS measurements in patients being evaluated for eCPR before ECMO initiation
Measured: 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
Measured: 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
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
Measured: 1 Month, 6 Months and 12 Months
Mortality
Mortality Rate at 1 month, 6 months, and 12 months
Measured: 1 month, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start12 May 2026
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Grafeneder, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584187
- Sponsor's protocol ID
- 2337/2025
- Acronym
- PERCEPTION
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super-Early Neuroprognostication in eCPR Patients: Feasibility of Automated Pupillometry and Cerebral Near-Infrared Spectroscopy - A Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT07584187
- Acronym / sponsor ID
- PERCEPTION / 2337/2025
- Conditions
- Resuscitation, Extra Corporeal Life Support, ECMO, Extracorporeal Cardiopulmonary Resuscitation
- Keywords
- eCPR, ECMO, CPR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine.
Key inclusion criteria (1 listed)
- All patients ≥ 18 years evaluated for eCPR treatment at the Department of Emergency Medicine
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated PupillometryPupils 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) | Diagnostic test | – |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided
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Sustained Cord Circulation at Emergency Cesarean Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resuscitation and Extra Corporeal Life Support, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Grafeender, MD, PhD (+43 1 40400 19540, juergen.grafeneder@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability of automated pupillometry (time frame: Before ECMO initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.