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NCT Number: NCT06642896

Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

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.

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Key information

Conditions

Children Brain Injury Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble Alpes, Grenoble, ISERE, France

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About this study

Traditionally, the pupillary light reflex is assessed using a simple light source, with subjective evaluation by a healthcare professional. However, this method has significant inter- and intra-individual variability. Quantitative pupillometry offers a more objective and reproducible way to evaluate pupillary reactivity. In adults, some parameters are well-known indicators of ICH, such as a constriction velocity of less than 0.6 mm/sec and a constriction percentage below 10%. The constriction percentage can be simplified with the Neurological Pupil index (NPI), which ranges from 0 to 5. An NPI of 4 or 5 is considered to indicate good pupillary reactivity. The two quantitative pupillometers currently on the market (Neurolight, Neuroptics) appear to provide similar data for most variables assessed. However, there are few studies evaluating this tool in pediatric patients with neurological injuries.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized in a pediatric intensive care unit or neurosurgical intensive care unit
  • 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

  • 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

Treatment and study plan

Pupillometer

Device

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

Primary outcomes

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

    Time frame: at 10 days

    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.

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

    Time frame: at 1 minute and 25 minutes

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

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

    Time frame: at 1 minute and 25 minutes

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

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

    Time frame: at 1 minute and 25 minutes

    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

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

    Time frame: at 1 minute and 25 minutes

    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

Secondary outcomes

  1. 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).

    Time frame: per 12h during 10 days

    Assessing the association between latency in sec (LAT) and ICP (mmhg)

  2. 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).

    Time frame: per 12h during 10 days

    Assessing the association between measurements of pupillometry, QPI, quantitative pupillometry index

  3. 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)

    Time frame: per 12h during 10 days

    Assessing the association between measurements of pupillometry, percentage of constriction (CON) and ICP.

  4. 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)

    Time frame: per 12h during 10 days

    To asses association between intracranial pressure and minimum et maximum pupillary diameter (in mm).

  5. 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)

    Time frame: per 12h during 10 days

    To asses association between ICP and pupillometry values : constriction velocity (ACV) and dilatation velocity (ADV) in mm.sec

  6. Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age

    Time frame: at 1 and 25 minutes

    measurement of pupillometric parameters : latence (in sec)

  7. Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.

    Time frame: at 1 and 25 minutes

    measurement of pupillometric parameters : quantitative pupillometry index, pupil constriction

  8. Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.

    Time frame: at 1 and 25 minutes

    measurement of pupillometric parameters : Minimum and maximum pupillary diameter (in mm)

  9. Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.

    Time frame: at 1 and 25 min

    measurement of pupillometric parameters constriction velocity (ACV), dilatation velocity (ADV) in mm/sec

  10. Describe the evolution of different pupillometry measurements before and after osmotherapy

    Time frame: at 15 , 25, 35, 45, 60, 120, 240 minutes

    Measure of pupillometry: CON and QPI after osmotherapy administration

  11. Describe the evolution of different pupillometry measurements before and after osmotherapy

    Time frame: [Time Frame: at 15 , 25, 35, 45, 60, 120, 240 minutes]

    Measure of pupillometry : constriction velocity (ACV), dilatation velocity (ADV) in mm/sec

  12. Describe the evolution of different pupillometry measurements before and after osmotherapy

    Time frame: [Time Frame: at 15 , 25, 35, 45, 60, 120, 240 minutes]

    Measure of pupillometry: latence (in mm)

  13. Describe the evolution of different pupillometry measurements before and after osmotherapy

    Time frame: at 15 , 25, 35, 45, 60, 120, 240 minutes

    Measure of pupillometry: Min and max pupillary diameter in mm.

  14. Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)

    Time frame: 2 times a day for 10 days or on discharge from hospital

    Repeated pupillometry measurements : (LAT) latence in sec and transcranial doppler

  15. Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)

    Time frame: 2 times a day for 10 days or on discharge from hospital

    Repeated pupillometry measurements QPI and CON and transcranial doppler

  16. Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)

    Time frame: 2 times a day for 10 days or on discharge from hospital

    Repeated pupillometry measurements (Maximum and minimum pupillary diameter in mm) and transcranial doppler

  17. Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)

    Time frame: 2 times a day for 10 days or on discharge from hospital

    Repeated pupillometry measurements (constriction velocity (ACV) and dilatation velocity (ADV) in mm.sec) and transcranial doppler

Study contacts

Contact information is provided by the study sponsor or research team.

Angélina AP POLLET, RESEARCH NURSE

CONTACT

[email protected]

0476766729 ext. +33

Sarah SS SINTZEL STRIPPPOLI, Doctor

CONTACT

[email protected]

0476766729 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: OSMOPUPILLO

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 15, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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