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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05567978
Acronym
LYNX
Enrollment
100
Registered
2022-10-05
Start date
2022-10-31
Completion date
2024-12-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pupillometry Index in Brain Lesion

Keywords

Brain lesion, pupillometry index, neurological outcome

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.

Interventions

PROCEDUREpupillometry index

Admission to the intensive care unit, measurement of pupillometry index every 4 hours for 7 days or at extubation of brain damaged patients

Sponsors

University Hospital Brussel
CollaboratorUNKNOWN
Ramon y Cajal University Hospital
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patientsat 7 daysThe NPI and QPI value between 0 and 5

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026