Study of Glasgow Coma Scale in Neurological Patients

NCT ID: NCT01641978

Last Updated: 2016-08-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Individuality

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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ICU patients

neurological level in critical patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* neurologic patients

Exclusion Criteria

* pregnants, under-ages
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Getafe

OTHER

Sponsor Role lead

Responsible Party

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Susana Arias Rivera

Graduada en Enfermería

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susana Arias, RN

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Getafe

Locations

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Hospital Universitario de Getafe

Getafe, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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GLASGOW GETAFE

Identifier Type: -

Identifier Source: org_study_id

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