Assignment of the Verbal Component Score and Addition of Pupil Reaction to the Glasgow Coma Scale

NCT05767502 | Unknown

• 1 other identifier: 2019-KAEK-140
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it is aimed to determine the prognostic value of GCS-P and the GCS-P score, which is formed by assigning a verbal score, in patients with traumatic brain injury, where all parameters can be evaluated. In the model to be created, a new total score will be obtained with Motor score + Eye Response + assigned verbal Score-Pupil score and this score will be compared with GCS and GCS-Pupil score.

Conditions

Brain Injuries, Traumatic

Keywords

GCS; GCS-Pupil score; Brain trauma; Consciousness

Outcome Measures

Primary Outcomes (2)

• MORTALITY

  Death of the patient while in the hospital

  From admission to discharge, an average of 1 weeks

• MORBIDTIY

  Patients with a Glasgow Outcome score of 2 and 3 (Each patient can get 1-5 points from the Glasgow Outcome score. A low score indicates a negative result.

  From admission to discharge, an average of 1 weeks

Secondary Outcomes (2)

• MORTALITY

  3 months after hospital discharge

• MORBIDITY

  3 months after hospital discharge

Interventions

GCS-Pupil score DIAGNOSTIC_TEST

GCS+attributed verbal score- Step 1 to obtain pupillary score: * Patients with a motor (M) and eye-opening response (E) total score between 2 and 6 are assigned a verbal score of +1 * Patients with an M+E score of 7 are assigned a verbal score of +2 * Patients with an M+E score of 8-9 are assigned a verbal score of +4 * Patients with an M+E score of 10 are assigned a verbal score of +5 GCS+attributed verbal score- Step 2 to obtain the pupillary score: The total score is obtained by subtracting the pupil score from the score obtained in the 1st step. Pupil score is scored as follows; * 0 points if both pupils react to light, * 1 point if a pupil does not react to light and has anisocoria, * 2 points if both pupils do not react to light

Also known as: GCS+attributed verbal score- Pupil score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

When α: 0.05 β: 0.20 and the acceptable difference between models were selected as 10% using the G-Power program, the number of patients to be included in the study was determined as 199.

You may qualify if:

• Admitted to hospital due to traumatic brain injury,
• years and older,
• who were alive at the time of admission,
• Patients whose GCS and pupil reactivity can be evaluated completely.

You may not qualify if:

• Younger than 18,
• Not alive at the time of admission,
• Patients whose GCS score and pupil reactivity are not correctly evaluated (facial trauma, past eye diseases or eye defects, etc.).

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa City Hospital

Bursa, 16000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

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: February 28, 2023
• First Posted: March 14, 2023
• Study Start: February 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)