Quantitative Pupillometry (HYDRO-NiP)
Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care.
Assessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs.
The aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jérôme DAUVERGNE, IDE
- Número de teléfono: 33 (0) 2.40.16.52.89
- Correo electrónico: jerome.dauvergne@chu-nantes.fr
Ubicaciones de estudio
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Nantes, Francia, 44093
- CHU de Nantes
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Contacto:
- Jérôme Dauvergne
- Correo electrónico: jerome.dauvergne@chu-nantes.fr
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Loire-Atlantique
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Nant, Loire-Atlantique, Francia, 44093
- Nantes University Hospital
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Contacto:
- Jérôme DAUVERGNE, IDE
- Número de teléfono: 33 (0) 2.40.16.52.89
- Correo electrónico: jerome.dauvergne@chu-nantes.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria :
- Patient older than 18 years old
- Admitted to the ICU
- With an external ventricular drain
- Consenting to participate (or consent from his/her next of kin, if unable to consent).
Exclusion Criteria :
- Patient with pre-existing bilateral pupillary pathology
- Pregnant or breast-feeding patient
- Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
- Patient with no health insurance
- Patient under guardianship
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test
Periodo de tiempo: 5 days
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NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test. Independently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal. Failing an occlusion test is defined by the need for reopening the EVD. |
5 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic evaluation
Periodo de tiempo: 5 days
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Pupillometer ability to detect an EDV occlusion test failure will be studied.
The area under the ROC curve (AUCROC) will be determined.
We define, a priori, that the detection performance will be, respectively, honorable, good or excellent if the AUCROC is higher than 0.70, 0.80 and 0.90.
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5 days
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Pupillometry and EVD occlusion test
Periodo de tiempo: 5 days
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Constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
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5 days
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Dilatation velocity
Periodo de tiempo: 5 days
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Dilation velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
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5 days
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Maximum constriction velocity
Periodo de tiempo: 5 days
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Maximum constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
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5 days
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Latency of contraction
Periodo de tiempo: 5 days
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Latency of contraction will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
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5 days
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Pupil size variation
Periodo de tiempo: 5 days
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Pupil size variation will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
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5 days
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Pupillometry and clinical scores
Periodo de tiempo: 5 days
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The association between pupillometry parameters and clinical scores (Glasgow Coma Scale, FOUR score, RASS and CAM-ICU) will be studied
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5 days
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The association between pupillometry parameters and ventricular volume will be studied.
Periodo de tiempo: 5 days
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A relationship between, measurements of ventricular volumes (via brain imaging examinations performed regardless of this study) and pupillometry parameters will be sought
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5 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jérôme DAUVERGNE, CHU de Nantes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC21_0078
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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