Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642896
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Quantitative Pupillometry in Brain Injury Children Variation After Osmotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quantitative Pupillometry in Brain Injury Children Variation After Osmotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSMOPUPILLO
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
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 06 mmsec 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None