Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy
- Conditions
- Children Brain Injury
- Registration Number
- NCT06642896
- Lead Sponsor
- University Hospital, Grenoble
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child. 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
to describe and evaluate the variation in the percentage of pupillary constriction (CON) before, and after osmotherapy in neuro-injured children. 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.
- Secondary Outcome Measures
Name Time Method 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 Assessing the association between latency in sec (LAT) and ICP (mmhg)
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 Assessing the association between measurements of pupillometry, QPI, quantitative pupillometry index
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 Assessing the association between measurements of pupillometry, percentage of constriction (CON) and ICP.
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 To asses association between intracranial pressure and minimum et maximum pupillary diameter (in mm).
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 To asses association between ICP and pupillometry values : constriction velocity (ACV) and dilatation velocity (ADV) in mm.sec
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age at 1 and 25 minutes measurement of pupillometric parameters : latence (in sec)
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age. at 1 and 25 min measurement of pupillometric parameters constriction velocity (ACV), dilatation velocity (ADV) in mm/sec
Describe the evolution of different pupillometry measurements before and after osmotherapy at 15 , 25, 35, 45, 60, 120, 240 minutes Measure of pupillometry: Min and max pupillary diameter in mm.
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd) 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
Trial Locations
- Locations (2)
Chu Grenoble Alpes
🇫🇷Grenoble, Isere, France
Grenoble Alpes University Hospital
🇫🇷La tronche, France