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Study of Glasgow Coma Scale in Neurological Patients

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ClinicalTrials.gov Identifier: NCT01641978
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Information provided by (Responsible Party):
Susana Arias Rivera, Hospital Universitario Getafe

Brief Summary:

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

Condition or disease

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
Actual Enrollment : 125 participants
Time Perspective: Prospective
Official Title: Study of Interobserver Correlation of Glasgow Coma Scale in Critical Neurological Patients
Study Start Date : January 2012
Primary Completion Date : January 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma
U.S. FDA Resources

ICU patients
neurological level in critical patients

Primary Outcome Measures :
  1. 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%

Secondary Outcome Measures :
  1. 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.

  2. Years of Professional Experience for Nurses in Critical Care [ Time Frame: 1 year ]
    Influence of professional experience in the evaluation of neurological patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
neurologic patients

Inclusion Criteria:

  • neurologic patients

Exclusion Criteria:

  • pregnants, under-ages

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641978

Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28009
Sponsors and Collaborators
Hospital Universitario Getafe
Principal Investigator: Susana Arias, RN Hospital Universitario de Getafe

Responsible Party: Susana Arias Rivera, Graduada en Enfermería, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01641978     History of Changes
Other Study ID Numbers: GLASGOW GETAFE
First Posted: July 17, 2012    Key Record Dates
Results First Posted: August 11, 2016
Last Update Posted: August 11, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No