Study of Glasgow Coma Scale in Neurological Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susana Arias Rivera, Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01641978
First received: July 13, 2012
Last updated: June 29, 2016
Last verified: June 2016
  Purpose

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
Individuality

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study of Interobserver Correlation of Glasgow Coma Scale in Critical Neurological Patients

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • Interobserver Correlation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Severity in Glasgow Coma Scale (GCS) by Groups. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.


  • Years of Professional Experience for Nurses in Critical Care [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Influence of professional experience in the evaluation of neurological patients


Enrollment: 125
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU patients
neurological level in critical patients

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.
  Eligibility

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

Inclusion Criteria:

  • neurologic patients

Exclusion Criteria:

  • pregnants, under-ages
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641978

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

Responsible Party: Susana Arias Rivera, Graduada en Enfermería, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01641978     History of Changes
Other Study ID Numbers: GLASGOW GETAFE 
Study First Received: July 13, 2012
Results First Received: July 1, 2013
Last Updated: June 29, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on August 25, 2016