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Clinical Trials/NCT05567978
NCT05567978
Completed
Not Applicable

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

University Hospital, Grenoble1 site in 1 country100 target enrollmentOctober 31, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pupillometry Index in Brain Lesion
Sponsor
University Hospital, Grenoble
Enrollment
100
Locations
1
Primary Endpoint
To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2022
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients

Time Frame: at 7 days

The NPI and QPI value between 0 and 5

Secondary Outcomes

  • To assess the relationship between pupillometry indices (NPI/QPI) and intracranial hypertension(at 7 days)
  • Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices(at 1 year)
  • To evaluate the contribution of the QPI and NPI indexes in predicting mortality and neurological outcome compared to existing scores (IMPACT, CRASH)(6 months)

Study Sites (1)

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