Clinical trial NCT05567978: Comparison of 2 Pupillometric Indices in Cerebral Brain Patients
Official title: Evaluation of the Correlation Between the 2 Pupillometry Indexes (QPI and NPI) in Cerebral Palsy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pupillometry Index in Brain Lesion
Keywords: Brain lesion
pupillometry index
neurological outcome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital Brussel
name: Ramon y Cajal University Hospital
First posted: 2022-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient admitted for a traumatic brain injury, intracranial hemorrhage, or subarachnoid hemorrhage and for whom a pupillometry indication is retained

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients
timeFrame: at 7 days
Secondary outcomes:
measure: To assess the relationship between pupillometry indices (NPI/QPI) and intracranial hypertension
timeFrame: at 7 days
measure: To evaluate the contribution of the QPI and NPI indexes in predicting mortality and neurological outcome compared to existing scores (IMPACT, CRASH)
timeFrame: 6 months
measure: Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices
timeFrame: at 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble ALPES
Study officials:
References:
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citation: Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.
citation: Couret D, Simeone P, Freppel S, Velly L. The effect of ambient-light conditions on quantitative pupillometry: a history of rubber cup. Neurocrit Care. 2019 Apr;30(2):492-493. doi: 10.1007/s12028-018-0664-z. No abstract available.
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