Study of Glasgow Coma Scale in Neurological Patients

June 29, 2016 updated by: Susana Arias Rivera, Hospital Universitario Getafe

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

Completed

Conditions

Detailed Description

Prospective observational study conducted in a multi-unit 18 beds, neurological and / or neurosurgical patients are included. Variables: Demographic, reason for admission, overall and its components GCS. The neurological assessment was performed by a minimum of 3 nurses. One of them applied algorithm and evaluation technique and all agreed independently valued response to stimuli. Interobserver agreement measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) of 95%. This study was approved by the Ethics Committee of Clinical Trials hospital.

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Getafe, Madrid, Spain, 28009
        • Hospital Universitario de Getafe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

neurologic patients

Description

Inclusion Criteria:

  • neurologic patients

Exclusion Criteria:

  • pregnants, under-ages

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ICU patients
neurological level in critical patients

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susana Arias, RN, Hospital Universitario de Getafe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

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)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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