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

Sponsor
Uludag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05419739
Collaborator
(none)
128
1
12
10.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Glasgow coma scale

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
Anticipated Enrollment :
128 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prognostic Value of Pediatric GCS-Pupil Score in Pediatric Patients With Traumatic Brain Injury
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1

Children under 18 years of age with traumatic brain injury

Other: Glasgow coma scale
This scale, which consists of three parameters, includes the best eye response (1-4 points), the best verbal response (1-5 points), and the best motor response (1-6 points). Total score; It is calculated as Eye Response + Verbal Response + Motor Response and takes a value between 3-15 points. The severity of head trauma is evaluated in three categories: mild (GCS 13-15 points), moderate (GCS 9-12 points), and severe (GCS ≤ 8 points).
Other Names:
  • Pediatric Cerebral Performance Category Scoring System
  • Outcome Measures

    Primary Outcome Measures

    1. Death rate [one year]

      Death

    Secondary Outcome Measures

    1. Adverse functional outcomes [one year]

      severely crippled or vegetative condition

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bursa Provincial Health Directorate University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Bursa Turkey 16000

    Sponsors and Collaborators

    • Uludag University

    Investigators

    • Principal Investigator: AKİF BULUT, MSc, Uludag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AKİF BULUT, Principal Investigator, Uludag University
    ClinicalTrials.gov Identifier:
    NCT05419739
    Other Study ID Numbers:
    • 2011-KAEK-25 2022/04-08
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AKİF BULUT, Principal Investigator, Uludag University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2022