Comparison of 2 Pupillometric Indices in Cerebral Brain Patients (LYNX)

November 7, 2022 updated by: University Hospital, Grenoble

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38000
        • Recruiting
        • Chu Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient admitted for a traumatic brain injury, intracranial hemorrhage, or subarachnoid hemorrhage and for whom a pupillometry indication is retained

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 7 days
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
6 months
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
at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC22.0245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Because of the observational/exploratory nature of the study, no formal sample size calculation has been performed. However, it is planned to recruit a total of at least 30 patients (traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage), over a 12-month period.

Data will be described in numbers and percentages for qualitative data, and in quartiles and means/standard deviation for quantitative characteristics.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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