Comparison of 2 Pupillometric Indices in Cerebral Brain Patients

Completed

• Conditions: Pupillometry Index in Brain Lesion

• Registration Number: NCT05567978
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-05
• Study Start: 2022-10-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients	at 7 days	The NPI and QPI value between 0 and 5

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Grenoble ALPES; 🇫🇷 Grenoble, France