Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

NCT06642896 | Recruiting

• 1 other identifier: 38RC24.0212
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Intracranial hypertension (ICH) is a common and serious complication in children admitted to pediatric intensive care units. It is primarily caused by traumatic brain injury but can also result from brain malformations, brain tumors, or neuro-meningeal infections. Rapid identification of ICH in acute settings is crucial to ensure prompt management and mitigate potential consequences, such as severe neurological sequelae or death. 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.

Conditions

Children Brain Injury

Keywords

brain lesion; pupillometry; assess variation in the percentage of pupillary constriction; children; severe head trauma

Outcome Measures

Primary Outcomes (5)

• to describe and evaluate the variation in the percentage of pupillary constriction (CON) before, and after osmotherapy in neuro-injured children.

  Delta (in percentage difference, and in delta of values) of the constriction (CON) between the last available measurement before the osmotherapy was started, and the measurement 5 minutes after the end (at 25 minutes after the start of the osmotherapy). For each child, the eye with the lowest constriction (CON) value before osmotherapy will be considered.

  at 10 days

• Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.

  Success rate in obtaining pupillometric values for different age groups. Pupillometric values: QPI (quantitative pupillometry index) in intensive care and the operating room

  at 1 minute and 25 minutes

• Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.

  Success rate in obtaining pupillometric values for different age groups. Pupillometric values: latency (LAT) in intensive care and the operating room

  at 1 minute and 25 minutes

• Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.

  Success rate in obtaining pupillometric values for different age groups. Pupillometric values: constriction velocity (ACV) and dilatation velocity (ADV) in mm/sec in intensive care and the operating room

  at 1 minute and 25 minutes

• Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.

  Success rate in obtaining pupillometric values for different age groups. Pupillometric values: minimum (MIN) and maximum (MAX) pupillary diameter in mm in intensive care and the operating room

  at 1 minute and 25 minutes

Secondary Outcomes (17)

• In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (LAT).

  per 12h during 10 days

• In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (QPI).

  per 12h during 10 days

• In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values.(CON)

  per 12h during 10 days

• In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (Max; Min)

  per 12h during 10 days

• In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values. (ACV and ADV)

  per 12h during 10 days

Study Arms (2)

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

Device: pupillometer

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

Device: pupillometer

Interventions

pupillometer DEVICE

describe the feasibility of pupillometry measurements in sedated but non-cerebrosed children in intensive care and the operating room

pupillometry measurement in non-cerebral pediatric patients

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children aged 1 month to 17 years with brain lesion receiving osmotherapy

You may qualify if:

• Hospitalized in a pediatric intensive care unit or neurosurgical intensive care unit
• with clinically suspected HTIC (disorders of consciousness with transcranial Doppler abnormality, symptoms of involvement, poor cerebral perfusion pressure) for which osmotherapy is prescribed

You may not qualify if:

• Presence of eye damage (or antecedent)
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

Chu Grenoble Alpes

Grenoble, ISERE, 387000, France

RECRUITING

Grenoble Alpes University Hospital

La Tronche, 38700, France

NOT YET RECRUITING

Related Publications (13)

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  PMID: 31555934 BACKGROUND

• 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.

  PMID: 16383247 BACKGROUND

• 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.

  PMID: 23433043 BACKGROUND

• 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.

  PMID: 32195898 BACKGROUND

• 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.

  PMID: 31033624 BACKGROUND

• 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.

  PMID: 31601157 BACKGROUND

• 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.

  PMID: 10232526 BACKGROUND

• Manley GT, Larson MD. Infrared pupillometry during uncal herniation. J Neurosurg Anesthesiol. 2002 Jul;14(3):223-8. doi: 10.1097/00008506-200207000-00009.

  PMID: 12172296 BACKGROUND

• 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.

  PMID: 33003179 BACKGROUND

• 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.

  PMID: 25735686 BACKGROUND

• 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.

  PMID: 35267036 BACKGROUND

• 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.

  PMID: 27838440 BACKGROUND

• 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.

  PMID: 21207041 BACKGROUND

Related Links

• Epidemiology of head injuries in France and other Western countries
• intracranial hypertension in infants

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Central Study Contacts

Sarah SS SINTZEL STRIPPPOLI, Doctor

CONTACT

0476766729; ssintzelstrippoli@chu-grenoble.fr

Angélina AP POLLET, RESEARCH NURSE

CONTACT

0476766729; apollet@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 15, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)