Comparison of 2 Pupillometric Indices in Cerebral Brain Patients

Study Overview
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Brief Summary
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Pupillary examination, and in particular pupillary reactivity to light, is fundamental to the monitoring and follow-up in intensive care units of patients with acute brain injury. A pupillometric index combining different parameters of pupillary light reflex has been described as predictive of intracranial hypertension and the neurological outcome of the patient.

Detailed Description
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Pupillary examination, and in particular pupillary reactivity to light, is fundamental for the monitoring and follow-up in intensive care units of patients with acute brain injury. Intracranial pressure monitoring and pupillometry measurement are thus part of the routine practice of intensive care unit management of brain injured patients. Furthermore, elevated intracranial pressure in brain injured patients admitted to the ICU is associated with a poor prognosis, and very high intracranial pressure is a life-threatening situation. A pupillometry index combining different parameters of pupillary light reflex has been described as having predictive value of intracranial hypertension and neurological outcome of the patient: the NPi. Another manufacturer IdMed, Marseille, France proposes an index: the QPI (Quantitative Pupillometry Index), based on a statistical classification of the amplitude of the light reflex. The aim of this study is to show that : QPI is equivalent to NPI An abnormal value of the pupillometry indexes (NPI/QPI) is predictive of high intracranial pressure. An abnormal value of pupillometry indexes (NPI/QPI) is predictive of a poor neurological outcome at 6 months.

Official Title
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Evaluation of the Correlation Between the 2 Pupillometry Indexes (QPI and NPI) in Cerebral Palsy Patients

Conditions
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Pupillometry Index in Brain Lesion

Intervention / Treatment
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* Procedure: pupillometry index


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age Patients admitted for any brain injury: traumatic, intracranial hemorrhage, subarachnoid hemorrhage Pupillometry available as a standard assessment tool. Patient intubated/ventilated for neurological reasons for more than 12 hours Exclusion Criteria: Non-intensive care patients Facial and or ocular trauma not allowing pupillometry evaluation Patients admitted to the ICU with a life expectancy of < 24 hours Protected persons (under guardianship, curators, pregnant or breastfeeding women, persons deprived of liberty, persons not subject to a psychiatric measure) Patients not affiliated to a social security system Patients who object to the use of their data for research purposes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pupillometry index|Admission to the intensive care unit, measurement of pupillometry index every 4 hours for 7 days or at extubation of brain damaged patients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients | The NPI and QPI value between 0 and 5 | at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the relationship between pupillometry indices (NPI/QPI) and intracranial hypertension | number of intracranial hypertension based on ICP value >5mns | at 7 days | 
| To evaluate the contribution of the QPI and NPI indexes in predicting mortality and neurological outcome compared to existing scores (IMPACT, CRASH) | GOS-E at 6 months | 6 months | 
| Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices | Satisfaction questionnaire for users ( not at all satisfied, moderately satisfied, very satisfied) scale from 0 to 100. 100 is the best score | at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain lesion, pupillometry index, neurological outcome