- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07584187
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Jürgen Grafeender, MD, PhD
- Telefonnummer: +43 1 40400 19540
- E-post: juergen.grafeneder@meduniwien.ac.at
Studieorter
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Vienna, Österrike, 1090
- Rekrytering
- Department of Emergency Medicine, Medical University of Vienna
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Feasability of automated pupillometry
Tidsram: Before ECMO initiation.
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The primary outcome is the rate of successful automated pupillometry measurements in patients being evaluated for eCPR before ECMO initiation.
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Before ECMO initiation.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasablity of cNIRS
Tidsram: before ECMO initiation
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Success rate of obtaining cNIRS measurements in patients being evaluated for eCPR before ECMO initiation
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before ECMO initiation
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Rate of acquiring automated pupillometry and cNIRS following ECMO initiation
Tidsram: 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
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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
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Mortality
Tidsram: 1 month, 6 months, and 12 months
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Mortality Rate at 1 month, 6 months, and 12 months
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1 month, 6 months, and 12 months
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Neurological Outcome
Tidsram: 1 Month, 6 Months and 12 Months
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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
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1 Month, 6 Months and 12 Months
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
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