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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 128

Contacts and Locations

• Study Contact: Name: AKİF BULUT, MSc; Phone Number: +90 546 872 28 72; Email: akifblt23@gmail.com

Study Locations

• Turkey
  • Bursa, Turkey, 16000
    • Bursa Provincial Health Directorate University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
    • Contact: HOSPITAL ethics committee; Phone Number: +90 224 295 50 00; Email: bursayuksekihtisaseah@saglik.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients younger than 18 years with traumatic brain injury

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death rate	Death	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse functional outcomes	severely crippled or vegetative condition	one year

Collaborators and Investigators

• Sponsor: Uludag University
• Investigators: Principal Investigator: AKİF BULUT, MSc, Uludag University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pediatric; Brain traumatic; GCS-Pupil score
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2011-KAEK-25 2022/04-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No