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

NCT05419739 | Unknown

• 1 other identifier: 2011-KAEK-25 2022/04-08
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Keywords

Brain traumatic; GCS-Pupil score; Pediatric

Outcome Measures

Primary Outcomes (1)

• Death rate

  Death

  one year

Secondary Outcomes (1)

• Adverse functional outcomes

  one year

Study Arms (1)

Group 1

Children under 18 years of age with traumatic brain injury

Other: Glasgow coma scale

Interventions

Glasgow coma scale 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).

Also known as: Pediatric Cerebral Performance Category Scoring System

Group 1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients younger than 18 years with traumatic brain injury

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

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

Bursa, 16000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Glasgow Coma Scale

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Trauma Severity Indices; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• AKİF BULUT, MSc

  Uludag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AKİF BULUT, MSc

CONTACT

+90 546 872 28 72; akifblt23@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)