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

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05419739
• Other study ID #: 2011-KAEK-25 2022/04-08
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: July 2023

Study information

• Verified date: June 2022
• Source: Uludag University
• Contact: AKIF BULUT, MSc
• Phone: +90 546 872 28 72
• Email: akifblt23[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
Turkey	Bursa Provincial Health Directorate University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death rate	Death	one year
Secondary	Adverse functional outcomes	severely crippled or vegetative condition	one year