NCT01641978

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

June 1, 2016

Enrollment Period

Same day

First QC Date

July 13, 2012

Results QC Date

July 1, 2013

Last Update Submit

June 29, 2016

Conditions

Individuality

Outcome Measures

Primary Outcomes (1)

  • Interobserver Correlation

    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 Outcomes (2)

  • Severity in Glasgow Coma Scale (GCS) by Groups.

    1 year

  • Years of Professional Experience for Nurses in Critical Care

    1 year

Study Arms (1)

ICU patients

neurological level in critical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

neurologic patients

You may qualify if:

  • neurologic patients

You may not qualify if:

  • pregnants, under-ages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28009, Spain

Location

Results Point of Contact

Title
Susana Arias Rivera
Organization
Hospital Universitario de Getafe
susana.arias@salud.madrid.org
+34916839360

Study Officials

  • Susana Arias, RN

    Hospital Universitario de Getafe

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduada en Enfermería

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 17, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

August 11, 2016

Results First Posted

August 11, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)