Comparison of 2 Pupillometric Indices in Cerebral Brain Patients

NCT05567978 | Completed

• 1 other identifier: 38RC22.0245
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pupillometry Index in Brain Lesion

Keywords

Brain lesion; pupillometry index; neurological outcome

Outcome Measures

Primary Outcomes (1)

• 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

  at 7 days

Secondary Outcomes (3)

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

  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)

  6 months

• Describe the satisfaction of the caregivers on the use of these 2 pupillometry devices

  at 1 year

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Hospital Brussel: collaborator
• Ramon y Cajal University Hospital: collaborator

Study Sites (1)

CHU Grenoble ALPES

Grenoble, France, 38000, France

Location

Related Publications (10)

• 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.

  PMID: 24522878 BACKGROUND

• Chen 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.

  PMID: 21748035 BACKGROUND

• Chen 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.

  PMID: 25332854 BACKGROUND

• Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.

  PMID: 25988634 BACKGROUND

• Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.

  PMID: 27329287 BACKGROUND

• Volpi 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.

  PMID: 30518336 BACKGROUND

• Han 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.

  PMID: 24568201 BACKGROUND

• Couret 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.

  PMID: 27072310 BACKGROUND

• Couret 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.

  PMID: 30604030 BACKGROUND

• Olson 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.

  PMID: 26381281 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 5, 2022
• Study Start: October 31, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)