Trials / Completed
CompletedNCT05567978
Comparison of 2 Pupillometric Indices in Cerebral Brain Patients
Evaluation of the Correlation Between the 2 Pupillometry Indexes (QPI and NPI) in Cerebral Palsy Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-10-31
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2022-10-05
- Last updated
- 2025-02-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05567978. Inclusion in this directory is not an endorsement.