Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy
NCT ID: NCT06642896
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-11-11
2028-04-01
Brief Summary
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The assessment of the pupillary light reflex is one of the key clinical parameters used to identify ICH in children with neurological injuries. This clinical sign is correlated with neurological prognosis. During an episode of ICH, regardless of the underlying cause, the oculomotor nerve becomes compressed between the midbrain and the temporal lobe, leading to anisocoria (unequal pupil sizes) and loss of pupillary reactivity. Other factors, such as episodes of ischemia or hypoperfusion in the midbrain, can also contribute to decreased pupillary reactivity.
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Detailed Description
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One study on quantitative pupillometry found that children with neurological injuries and an intracranial pressure (ICP) above 20 mmHg had significantly lower pupillary reactivity, NPI, constriction percentage, and dilation and constriction velocities compared to children without ICH.
Osmotherapy is a commonly used pharmacological intervention in pediatrics to lower intracranial pressure and improve cerebral perfusion pressure. Based on the work of Freeman et al., we hypothesize that the pupillary constriction percentage improves after osmotherapy in children with neurological injuries.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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severe head trauma in children with osmotherapy treatment
Admission to the pediatric intensive care or neurosurgical intensive care unit, pupillometry measurement before and after osmotherapy treatment
pupillometer
Pupillometry measurements at 5 and 25 minutes for children treated with osmotherapy, followed by measurements twice a day during hospitalization in the intensive care unit
pupillometry measurement in non-cerebral pediatric patients
feasibility of pupillometry in children for different age groups and obtain baseline values for non-neurologically sedated children in 4 age groups from 0 to 17 years of age in intensive care and the operating room
pupillometer
describe the feasibility of pupillometry measurements in sedated but non-cerebrosed children in intensive care and the operating room
Interventions
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pupillometer
describe the feasibility of pupillometry measurements in sedated but non-cerebrosed children in intensive care and the operating room
pupillometer
Pupillometry measurements at 5 and 25 minutes for children treated with osmotherapy, followed by measurements twice a day during hospitalization in the intensive care unit
Eligibility Criteria
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Inclusion Criteria
* Inclusion within 24 hours of ICU admission
* with clinically suspected HTIC (disorders of consciousness with transcranial Doppler abnormality, symptoms of involvement, poor cerebral perfusion pressure) for which osmotherapy is prescribed
Exclusion Criteria
* Refusal by parents and/or child Opposition by child or parental guardians.
* Persons not affiliated to the social security system.
* Protected persons (under guardianship, curatorship, pregnant or breast- feeding women, persons deprived of their liberty, persons not subject to a psychiatric measure
1 Month
17 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Chu Grenoble Alpes
Grenoble, ISERE, France
Grenoble Alpes University Hospital
La Tronche, , France
Countries
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Central Contacts
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Facility Contacts
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SARAH SS SINTZEL STRIPPOLI, PRINCIPAL INVESTIGATOR
Role: primary
References
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Winston M, Zhou A, Rand CM, Dunne EC, Warner JJ, Volpe LJ, Pigneri BA, Simon D, Bielawiec T, Gordon SC, Vitez SF, Charnay A, Joza S, Kelly K, Panicker C, Rizvydeen S, Niewijk G, Coleman C, Scher BJ, Reed DW, Hockney SM, Buniao G, Stewart T, Trojanowski L, Brogadir C, Price M, Kenny AS, Bradley A, Volpe NJ, Weese-Mayer DE. Pupillometry measures of autonomic nervous system regulation with advancing age in a healthy pediatric cohort. Clin Auton Res. 2020 Feb;30(1):43-51. doi: 10.1007/s10286-019-00639-3. Epub 2019 Sep 25.
Boev AN, Fountas KN, Karampelas I, Boev C, Machinis TG, Feltes C, Okosun I, Dimopoulos V, Troup C. Quantitative pupillometry: normative data in healthy pediatric volunteers. J Neurosurg. 2005 Dec;103(6 Suppl):496-500. doi: 10.3171/ped.2005.103.6.0496.
Rouche O, Wolak-Thierry A, Destoop Q, Milloncourt L, Floch T, Raclot P, Jolly D, Cousson J. Evaluation of the depth of sedation in an intensive care unit based on the photo motor reflex variations measured by video pupillometry. Ann Intensive Care. 2013 Feb 22;3(1):5. doi: 10.1186/2110-5820-3-5.
Freeman AD, McCracken CE, Stockwell JA. Automated Pupillary Measurements Inversely Correlate With Increased Intracranial Pressure in Pediatric Patients With Acute Brain Injury or Encephalopathy. Pediatr Crit Care Med. 2020 Aug;21(8):753-759. doi: 10.1097/PCC.0000000000002327.
Robba C, Moro Salihovic B, Pozzebon S, Creteur J, Oddo M, Vincent JL, Taccone FS. Comparison of 2 Automated Pupillometry Devices in Critically III Patients. J Neurosurg Anesthesiol. 2020 Oct;32(4):323-329. doi: 10.1097/ANA.0000000000000604.
Bower MM, Sweidan AJ, Xu JC, Stern-Neze S, Yu W, Groysman LI. Quantitative Pupillometry in the Intensive Care Unit. J Intensive Care Med. 2021 Apr;36(4):383-391. doi: 10.1177/0885066619881124. Epub 2019 Oct 10.
Ritter AM, Muizelaar JP, Barnes T, Choi S, Fatouros P, Ward J, Bullock MR. Brain stem blood flow, pupillary response, and outcome in patients with severe head injuries. Neurosurgery. 1999 May;44(5):941-8. doi: 10.1097/00006123-199905000-00005.
Manley GT, Larson MD. Infrared pupillometry during uncal herniation. J Neurosurg Anesthesiol. 2002 Jul;14(3):223-8. doi: 10.1097/00008506-200207000-00009.
Rameshkumar R, Bansal A, Singhi S, Singhi P, Jayashree M. Randomized Clinical Trial of 20% Mannitol Versus 3% Hypertonic Saline in Children With Raised Intracranial Pressure Due to Acute CNS Infections. Pediatr Crit Care Med. 2020 Dec;21(12):1071-1080. doi: 10.1097/PCC.0000000000002557.
Piper BJ, Harrigan PW. Hypertonic saline in paediatric traumatic brain injury: a review of nine years' experience with 23.4% hypertonic saline as standard hyperosmolar therapy. Anaesth Intensive Care. 2015 Mar;43(2):204-10. doi: 10.1177/0310057X1504300210.
Kochanek PM, Adelson PD, Rosario BL, Hutchison J, Miller Ferguson N, Ferrazzano P, O'Brien N, Beca J, Sarnaik A, LaRovere K, Bennett TD, Deep A, Gupta D, Willyerd FA, Gao S, Wisniewski SR, Bell MJ; ADAPT Investigators. Comparison of Intracranial Pressure Measurements Before and After Hypertonic Saline or Mannitol Treatment in Children With Severe Traumatic Brain Injury. JAMA Netw Open. 2022 Mar 1;5(3):e220891. doi: 10.1001/jamanetworkopen.2022.0891.
Rallis D, Poulos P, Kazantzi M, Chalkias A, Kalampalikis P. Effectiveness of 7.5% hypertonic saline in children with severe traumatic brain injury. J Crit Care. 2017 Apr;38:52-56. doi: 10.1016/j.jcrc.2016.10.014. Epub 2016 Oct 21.
Melo JR, Di Rocco F, Blanot S, Cuttaree H, Sainte-Rose C, Oliveira-Filho J, Zerah M, Meyer PG. Transcranial Doppler can predict intracranial hypertension in children with severe traumatic brain injuries. Childs Nerv Syst. 2011 Jun;27(6):979-84. doi: 10.1007/s00381-010-1367-8. Epub 2011 Jan 5.
Related Links
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Epidemiology of head injuries in France and other Western countries
intracranial hypertension in infants
Other Identifiers
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38RC24.0212
Identifier Type: -
Identifier Source: org_study_id
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