UMIN-CTR Clinical Trial

Public title

A multi-center comparative study of three coma scales: Japan Coma Scale, Glasgow Coma Scale and Emergency Coma
Scale : E-COMET STEP I

Acronym

E-COMET STEP I

Scientific Title

A multi-center comparative study of three coma scales: Japan Coma Scale, Glasgow Coma Scale and Emergency Coma
Scale : E-COMET STEP I

Scientific Title:Acronym

E-COMET STEP I

Region

Japan

Condition

consciousness disturbance

Classification by specialty

Emergency medicine

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1)We evaluate whether agreement scored among plural medical staff in same patients are improved at ECS comparison with JCS and GCS.
2)We compare agreement classified by disease, and evaluate it can reflect exact level of consciousness in which disease.
3)We evaluate the relationship in patients between scores and outcome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Japan Coma Scale, Glasgow Coma Scale,
Emergency Coma Scale, Glasgow Outcome Scale

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

7

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patients transported by ambulance car more than 7 years old who can follow some orders when they are alert.

Key exclusion criteria

patients who were not evaluated their level of consciousness more than two medical staff.

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Chiaki Takahashi

Organization

Graduate School of Medicine, University of Toyama

Division name

Department of Crisis Medicine

Zip code

Address

2630 Sugitani, Toyama-shi

TEL

076-434-7786

Email

Name of contact person

1st name
Middle name
Last name	Chiaki Takahashi

Organization

Graduate School of Medicine, University of Toyama

Division name

Department of Crisis Medicine

Zip code

Address

2630Sugitani, Toyama-shi

TEL

076-434-7786

Homepage URL

http://www.ecs.gr.jp

Email

d0661014@ems.u-toyama.ac.jp

Institute

Japan ECS Society

Institute

Department

Personal name

Organization

Japan ECS Society

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Hokuriku Emergency and Disaster Medicine Organization

Name of secondary funder(s)

The Japan Society of Neurosurgical Emergency
The Japan Society of Neurological Emergency

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

04

Month

05

Day

URL releasing protocol

http://www.ecs.gr.jp

Publication of results

Partially published

URL related to results and publications

http://www.ecs.gr.jp

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2007

Year

03

Month

22

Day

Date of IRB

Anticipated trial start date

2007

Year

04

Month

01

Day

Last follow-up date

2008

Year

10

Month

01

Day

Date of closure to data entry

2008

Year

11

Month

01

Day

Date trial data considered complete

2008

Year

11

Month

01

Day

Date analysis concluded

2008

Year

12

Month

01

Day

Other related information

The subject is all patients who are transported to Emergency Room(ER) of participating institutions(36 institutions).
When patients arrive at ER, at once, all member of covering team evaluate the level of consciousness by ECS, JCS and GCS. The occupations of member of the team include doctor, training doctor, nurse, emergency medical technician, medical student. We suppose that before hand, they studied the way of evaluation of three scores and understood. Contents of evaluation records are like this: coma scale participants are using usually (JCS, GCS, both), the time and date raters evaluated patients' level of consciousness, patients' level of consciousness evaluated by three coma scale, disease of patients, patients' outcome when they left the hospital (Glasgow Outcome Scale), complications effected on patients' outcome.
When we tally up and analyze this questionnaire, we will classify them into subgroup of category of the disease and coma scale raters are using usually. We will compare coincidence rate of plural evaluation value at same patient, relationship with outcome, and agreement classified in disease among the three coma scores. Every three scale, we will analyze the reliability among raters by kappa coefficient and intraclass correlation. Also, analyze every occupation and every disease of patients similarly. About the relationship between three scale and outcome, examine regression model.

Registered date

2007

Year

04

Month

04

Day

Last modified on

2008

Year

12

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000806