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

NCT ID: NCT05767502

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-06-01

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

Study Design

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

Interventions

GCS-Pupil score

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

GCS+attributed verbal score- Pupil score

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.).

• Minimum 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

Locations

Bursa City Hospital

Bursa, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

BURSA CITY HOSPITAL ethics committee, ethics

Role: primary

bursasehir@saglik.gov.tr

02249750000 ext. 1150

Other Identifiers

2019-KAEK-140

Identifier Type: -

Identifier Source: org_study_id