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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000671
Receipt No. R000000807
Scientific Title Comparative study of three coma scale:Japan Coma Scale, Glasgow Coma Scale and Emergency Coma Scale -from internet investigation- :E-COMET STEP II
Date of disclosure of the study information 2007/04/05
Last modified on 2009/10/04

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Basic information
Public title Comparative study of three coma scale:Japan Coma Scale,
Glasgow Coma Scale and Emergency Coma Scale -from internet investigation-
:E-COMET STEP II
Acronym E-COMET STEP II
Scientific Title Comparative study of three coma scale:Japan Coma Scale,
Glasgow Coma Scale and Emergency Coma Scale -from internet investigation-
:E-COMET STEP II
Scientific Title:Acronym E-COMET STEP II
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)Comparison between 3 scales about agreement among raters at the same patients.
(2)Evaluation of the accuracy about 3scale.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We limit occupation of raters :medical doctor, training doctor, nurse, emergency medical technician, medical student.
Key exclusion criteria someone who were not 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 2630 Sugitani, 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 Unpublished

Result
URL related to results and publications
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
2009 Year 10 Month 01 Day
Date of closure to data entry
2009 Year 10 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2010 Year 02 Month 01 Day

Other
Other related information Subjects are raters We will request 36 participating facility to join in research period. First, raters look at flash animation of patients exhibiting at ECS committee web site and next, evaluate patients' level of consciousness by JCS, GCS and ECS. The occupations of raters are medical doctor, training doctor, nurse, emergency medical technician, medical student.
We will take analysis of agreement using weighted kappa and intraclass correlation; multiple logistic regression for analyzing the difference among raters with respect to correct answer.

Management information
Registered date
2007 Year 04 Month 04 Day
Last modified on
2009 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000807

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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