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Study of Glasgow Coma Scale in Neurological Patients

Study of Interobserver Correlation of Glasgow Coma Scale in Critical Neurological Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01641978
Enrollment
125
Registered
2012-07-17
Start date
2012-01-31
Completion date
2013-01-31
Last updated
2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuality

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

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.

Interventions

None listed

Sponsors

Hospital Universitario Getafe
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* neurologic patients

Exclusion criteria

* pregnants, under-ages

Design outcomes

Primary

MeasureTime frameDescription
Interobserver Correlation1 yearinterobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) 95%

Secondary

MeasureTime frameDescription
Severity in Glasgow Coma Scale (GCS) by Groups.1 yearThe 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 Care1 yearInfluence of professional experience in the evaluation of neurological patients

Countries

Spain

Participant flow

Recruitment details

neurological and neurosurgical patients

Participants by arm

ArmCount
Neurologic Level
Neurologic patients
125
Total125

Baseline characteristics

CharacteristicNeurologic Level
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
58 Participants
Age, Categorical
Between 18 and 65 years
67 Participants
Age, Continuous62 years
STANDARD_DEVIATION 15
Region of Enrollment
Spain
125 participants
Sex: Female, Male
Female
43 Participants
Sex: Female, Male
Male
82 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 125
serious
Total, serious adverse events
0 / 125

Outcome results

Primary

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%

Time frame: 1 year

ArmMeasureValue (NUMBER)
Neurologic LevelInterobserver Correlation98.9 percentage of correlation
Secondary

Severity in Glasgow Coma Scale (GCS) by Groups.

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.

Time frame: 1 year

Population: Neurological and/or neurosurgical patients in ICU

ArmMeasureValue (NUMBER)
Neurologic LevelSeverity in Glasgow Coma Scale (GCS) by Groups.95.0 percentage of correlation
ModerateSeverity in Glasgow Coma Scale (GCS) by Groups.60.3 percentage of correlation
SlightSeverity in Glasgow Coma Scale (GCS) by Groups.90.3 percentage of correlation
Secondary

Years of Professional Experience for Nurses in Critical Care

Influence of professional experience in the evaluation of neurological patients

Time frame: 1 year

Population: Nurses with a minimum experience of three years in intensive care

ArmMeasureValue (MEDIAN)
Neurologic LevelYears of Professional Experience for Nurses in Critical Care14 years

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026