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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000670
Receipt No. R000000806
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
Date of disclosure of the study information 2007/04/05
Last modified on 2008/12/08

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Basic information
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
Condition consciousness disturbance
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Japan Coma Scale, Glasgow Coma Scale,
Emergency Coma Scale, Glasgow Outcome Scale
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Japan ECS Society
Institute
Department

Funding Source
Organization Japan ECS Society
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

Other related organizations
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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 04 Month 05 Day

Related information
URL releasing protocol http://www.ecs.gr.jp
Publication of results Partially published

Result
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

Progress
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
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.

Management information
Registered date
2007 Year 04 Month 04 Day
Last modified on
2008 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000806

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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