- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641978
Study of Glasgow Coma Scale in Neurological Patients
Study of Interobserver Correlation of Glasgow Coma Scale in Critical Neurological Patients
The assessment of the level of consciousness in patients admitted to intensive care units (ICU) can be complicated because the variables that are evaluated can be interpreted in a different way by different observers.
The main objective is to determine interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses and assess whether professional experience change the results. Secondary objective: to determine interobserver agreement in each of the three components (motor response, verbal and eye opening) of the GCS
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Madrid
-
Getafe, Madrid, Spain, 28009
- Hospital Universitario de Getafe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- neurologic patients
Exclusion Criteria:
- pregnants, under-ages
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
ICU patients
neurological level in critical patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interobserver Correlation
Time Frame: 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%
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity in Glasgow Coma Scale (GCS) by Groups.
Time Frame: 1 year
|
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. |
1 year
|
Years of Professional Experience for Nurses in Critical Care
Time Frame: 1 year
|
Influence of professional experience in the evaluation of neurological patients
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susana Arias, RN, Hospital Universitario de Getafe
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GLASGOW GETAFE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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