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Clinical Trials/NCT05419739
NCT05419739UnknownNot Applicable

Prognostic Value of Pediatric GCS-Pupil Score in Pediatric Patients With Traumatic Brain Injury

Uludag University1 site in 1 country128 target enrollmentStarted: July 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
128
Locations
1
Primary Endpoint
Death rate

Study Overview

Brief Summary

There are studies reporting that the survival rate in pediatric patients with abnormal pupillary response is 23% and that pupillary response is effective on mortality and patient outcomes. Studies in the literature examining the effect of pupillary response on mortality and outcome in pediatric patients with traumatic brain injury reported that bilaterally dilated pupils were associated with a higher mortality rate.

Considering the literature results, we believe that obtaining the GCS-Pupil score by combining GCS and pupillary reaction in pediatric patients with traumatic brain injury will be effective in predicting patient outcomes.

Detailed Description

Obtaining a GCS-Pupil score using the total GCS score: 0 points are given for pupillary reaction if both pupils react to light, 1 point if one pupil does not react to light, and 2 points if both pupils do not react to light. Total GCS-P score is calculated by the formula of Eye Response + Verbal Response + Motor Response - Pupil Reaction and scores between 1-15.

In the study, the worst GCS and current pupillary light reaction score in the first 24 hours will be evaluated.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Be under the age of 18,
  • •Not having mental and motor developmental retardation,
  • •Having had a traumatic brain injury,
  • •Alive at admission and followed up for at least 24 hours

Exclusion Criteria

  • •Eye trauma or severe facial trauma that will affect the assessment,
  • •Those under deep sedation,
  • •Those who have been administered drugs (Atropine and mydriatic) that will affect the pupillary response.

Outcomes

Primary Outcomes

Death rate

Time Frame: one year

Death

Secondary Outcomes

  • Adverse functional outcomes(one year)

Investigators

Sponsor
Uludag University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AKİF BULUT

Principal Investigator

Uludag University

Study Sites (1)

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