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Completed

NCT Number: NCT05567978

Comparison of 2 Pupillometric Indices in Cerebral Brain Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble ALPES

Grenoble, France, 38000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pupillometry index

Procedure

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

Primary outcomes

  1. 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

  1. To assess the relationship between pupillometry indices (NPI/QPI) and intracranial hypertension

    Time frame: at 7 days

    number of intracranial hypertension based on ICP value >5mns

  2. To evaluate the contribution of the QPI and NPI indexes in predicting mortality and neurological outcome compared to existing scores (IMPACT, CRASH)

    Time frame: 6 months

    GOS-E at 6 months

  3. Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Ramon y Cajal University Hospital
  • University Hospital Brussel

Registry information

Official study title

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

Acronym: LYNX

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2022
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.