UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000671 |
|---|---|
| Receipt number | 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 12:33:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
d0661014@ems.u-toyama.ac.jp
Sponsor or person
Institute
Japan ECS Society
Institute
Department
Personal name
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
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
Value
https://center6.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 |
