Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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: QPI (quantitative pupillometry index) in intensive care and the operating room
• 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: latency (LAT) in intensive care and the operating room
• 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: constriction velocity (ACV) and dilatation velocity (ADV) in mm/sec in intensive care and the operating room
• 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

Trial sites (2)

More University Hospital, Grenoble trials in France