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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jürgen Grafeender, MD, PhD
- Número de teléfono: +43 1 40400 19540
- Correo electrónico: juergen.grafeneder@meduniwien.ac.at
Ubicaciones de estudio
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Vienna, Austria, 1090
- Reclutamiento
- Department of Emergency Medicine, Medical University of Vienna
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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).
Plan de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasability of automated pupillometry
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasablity of cNIRS
Periodo de tiempo: 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
Periodo de tiempo: 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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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2337/2025
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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