Pupillometry Index in Brain LesionLYNXNCT05567978
Comparison of 2 Pupillometric Indices in Cerebral Brain Patients
An observational study of Pupillometry Index in Brain Lesion, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pupillometry Index in Brain Lesion
- What is being tested?
- pupillometry index
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2022to 31 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient admitted for a traumatic brain injury, intracranial hemorrhage, or subarachnoid hemorrhage and for whom a pupillometry indication is retained
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Pupillometry Index in Brain Lesion
- Being tested
- pupillometry index
- Keywords
- Brain lesion, pupillometry index, neurological outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pupillometry indexProcedure or surgery
Admission to the intensive care unit, measurement of pupillometry index every 4 hours for 7 days or at extubation of brain damaged patients
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients
The NPI and QPI value between 0 and 5
Measured: at 7 days
Secondary outcomes (3)
To assess the relationship between pupillometry indices (NPI/QPI) and intracranial hypertension
number of intracranial hypertension based on ICP value >5mns
Measured: 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)
GOS-E at 6 months
Measured: 6 months
Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices
Satisfaction questionnaire for users ( not at all satisfied, moderately satisfied, very satisfied) scale from 0 to 100. 100 is the best score
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start31 Oct 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pupillometry Index in Brain LesionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Brussel, Ramon y Cajal University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567978
- Sponsor's protocol ID
- 38RC22.0245
- Acronym
- LYNX
- Status last verified
- Feb 2025
- First submitted
- 23 Sep 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
Sharshar T, Citerio G, Andrews PJ, Chieregato A, Latronico N, Menon DK, Puybasset L, Sandroni C, Stevens RD. Neurological examination of critically ill patients: a pragmatic approach. Report of an ESICM expert panel. Intensive Care Med. 2014 Apr;40(4):484-95. doi: 10.1007/s00134-014-3214-y. Epub 2014 Feb 13.
PubMed 24522878Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
PubMed 21748035Chen JW, Vakil-Gilani K, Williamson KL, Cecil S. Infrared pupillometry, the Neurological Pupil index and unilateral pupillary dilation after traumatic brain injury: implications for treatment paradigms. Springerplus. 2014 Sep 23;3:548. doi: 10.1186/2193-1801-3-548. eCollection 2014.
PubMed 25332854Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
PubMed 25988634Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.
PubMed 27329287Volpi PC, Robba C, Rota M, Vargiolu A, Citerio G. Trajectories of early secondary insults correlate to outcomes of traumatic brain injury: results from a large, single centre, observational study. BMC Emerg Med. 2018 Dec 5;18(1):52. doi: 10.1186/s12873-018-0197-y.
PubMed 30518336Han J, King NK, Neilson SJ, Gandhi MP, Ng I. External validation of the CRASH and IMPACT prognostic models in severe traumatic brain injury. J Neurotrauma. 2014 Jul 1;31(13):1146-52. doi: 10.1089/neu.2013.3003. Epub 2014 May 12.
PubMed 24568201Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.
PubMed 27072310Couret D, Simeone P, Freppel S, Velly L. The effect of ambient-light conditions on quantitative pupillometry: a history of rubber cup. Neurocrit Care. 2019 Apr;30(2):492-493. doi: 10.1007/s12028-018-0664-z. No abstract available.
PubMed 30604030Olson DM, Stutzman S, Saju C, Wilson M, Zhao W, Aiyagari V. Interrater Reliability of Pupillary Assessments. Neurocrit Care. 2016 Apr;24(2):251-7. doi: 10.1007/s12028-015-0182-1.
PubMed 26381281Bouzat P, Blandino-Ortiz A, Vilotitch A, Pollet A, Zorzi S, Vathi S, Polato M, Gauss T, Taccone FS. Comparison of two automated pupillometry indices in patients with acute brain injury: the prospective multicentre LYNX cohort study. Crit Care. 2026 Sep 28;30(1):515. doi: 10.1186/s13054-026-06360-8.
PubMed 42839269
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correlation Between the 2 Pupillometry Indexes (QPI and NPI) in Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT05567978
- Acronym / sponsor ID
- LYNX / 38RC22.0245
- Conditions
- Pupillometry Index in Brain Lesion
- Keywords
- Brain lesion, pupillometry index, neurological outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital Brussel, Ramon y Cajal University Hospital
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient admitted for a traumatic brain injury, intracranial hemorrhage, or subarachnoid hemorrhage and for whom a pupillometry indication is retained
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pupillometry indexAdmission to the intensive care unit, measurement of pupillometry index every 4 hours for 7 days or at extubation of brain damaged patients | Procedure or surgery | – |
Primary outcome
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
3 secondary outcomes
To assess the relationship between pupillometry indices (NPI/QPI) and intracranial hypertension
Time frame: 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
Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices
Time frame: at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 24522878Sharshar T, Citerio G, Andrews PJ, Chieregato A, Latronico N, Menon DK, Puybasset L, Sandroni C, Stevens RD. Neurological examination of critically ill patients: a pragmatic approach. Report of an ESICM expert panel. Intensive Care Med. 2014 Apr;40(4):484-95. doi: 10.1007/s00134-014-3214-y. Epub 2014 Feb 13.
- Background: PubMed 21748035Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
- Background: PubMed 25332854Chen JW, Vakil-Gilani K, Williamson KL, Cecil S. Infrared pupillometry, the Neurological Pupil index and unilateral pupillary dilation after traumatic brain injury: implications for treatment paradigms. Springerplus. 2014 Sep 23;3:548. doi: 10.1186/2193-1801-3-548. eCollection 2014.
- Background: PubMed 25988634Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
- Background: PubMed 27329287Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.
- Background: PubMed 30518336Volpi PC, Robba C, Rota M, Vargiolu A, Citerio G. Trajectories of early secondary insults correlate to outcomes of traumatic brain injury: results from a large, single centre, observational study. BMC Emerg Med. 2018 Dec 5;18(1):52. doi: 10.1186/s12873-018-0197-y.
- Background: PubMed 24568201Han J, King NK, Neilson SJ, Gandhi MP, Ng I. External validation of the CRASH and IMPACT prognostic models in severe traumatic brain injury. J Neurotrauma. 2014 Jul 1;31(13):1146-52. doi: 10.1089/neu.2013.3003. Epub 2014 May 12.
- Background: PubMed 27072310Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.
- Background: PubMed 30604030Couret D, Simeone P, Freppel S, Velly L. The effect of ambient-light conditions on quantitative pupillometry: a history of rubber cup. Neurocrit Care. 2019 Apr;30(2):492-493. doi: 10.1007/s12028-018-0664-z. No abstract available.
- Background: PubMed 26381281Olson DM, Stutzman S, Saju C, Wilson M, Zhao W, Aiyagari V. Interrater Reliability of Pupillary Assessments. Neurocrit Care. 2016 Apr;24(2):251-7. doi: 10.1007/s12028-015-0182-1.
- Derived from this study: PubMed 42839269Bouzat P, Blandino-Ortiz A, Vilotitch A, Pollet A, Zorzi S, Vathi S, Polato M, Gauss T, Taccone FS. Comparison of two automated pupillometry indices in patients with acute brain injury: the prospective multicentre LYNX cohort study. Crit Care. 2026 Sep 28;30(1):515. doi: 10.1186/s13054-026-06360-8.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pupillometry Index in Brain Lesion, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the correlation of the 2 existing NPI pupillometry index ans the IPQ in cerebral palsy patients (time frame: at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567978, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.