Trial Outcomes & Findings for Study of Glasgow Coma Scale in Neurological Patients (NCT NCT01641978)

NCT ID: NCT01641978

Last Updated: 2016-08-11

Results Overview

interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) 95%

• Recruitment status: COMPLETED
• Target enrollment: 125 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-08-11

Participant Flow

neurological and neurosurgical patients

Participant milestones

Measure	Neurologic Level Neurologic patients
Overall Study STARTED	125
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Glasgow Coma Scale in Neurological Patients

Baseline characteristics by cohort

Measure	Neurologic Level n=125 Participants Neurologic patients
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants
Region of Enrollment Spain	125 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) 95%

Outcome measures

Measure	Neurologic Level n=125 Participants Neurologic patients	Moderate patients with GCS 9 - 12 points	Slight patients with GCS \> 12 points
Interobserver Correlation	98.9 percentage of correlation Interval 98.5 to 99.2	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Neurological and/or neurosurgical patients in ICU

The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).

Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).

It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness.

Outcome measures

Measure	Neurologic Level n=53 Participants Neurologic patients	Moderate n=39 Participants patients with GCS 9 - 12 points	Slight n=33 Participants patients with GCS \> 12 points
Severity in Glasgow Coma Scale (GCS) by Groups.	95.0 percentage of correlation Interval 91.9 to 96.1	60.3 percentage of correlation Interval 31.0 to 78.4	90.3 percentage of correlation Interval 81.8 to 95.2

SECONDARY outcome

Timeframe: 1 year

Population: Nurses with a minimum experience of three years in intensive care

Influence of professional experience in the evaluation of neurological patients

Outcome measures

Measure	Neurologic Level n=6 Participants Neurologic patients	Moderate patients with GCS 9 - 12 points	Slight patients with GCS \> 12 points
Years of Professional Experience for Nurses in Critical Care	14 years Interval 3.0 to 17.0	—	—

Adverse Events

Neurologic Level

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susana Arias Rivera

Hospital Universitario de Getafe

Phone: +34916839360

Email: susana.arias@salud.madrid.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place