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

NCT ID: NCT05419739

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-07-31

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Children under 18 years of age with traumatic brain injury

Glasgow coma scale

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

Pediatric Cerebral Performance Category Scoring System

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

AKİF BULUT

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AKİF BULUT, MSc

Role: PRINCIPAL_INVESTIGATOR

Uludag University

Locations

Bursa Provincial Health Directorate University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

AKİF BULUT, MSc

Role: CONTACT

akifblt23@gmail.com

+90 546 872 28 72

Facility Contacts

HOSPITAL ethics committee

Role: primary

bursayuksekihtisaseah@saglik.gov.tr

+90 224 295 50 00

Other Identifiers

2011-KAEK-25 2022/04-08

Identifier Type: -

Identifier Source: org_study_id