UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031427 |
|---|---|
| Receipt number | R000035816 |
| Scientific Title | Efficacy of transesophageal echocardiography simulator training: Randomized controlled trial |
| Date of disclosure of the study information | 2018/02/25 |
| Last modified on | 2018/04/07 16:17:52 |
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Basic information
Public title
Efficacy of transesophageal echocardiography simulator training: Randomized controlled trial
Acronym
Efficacy of transesophageal echocardiography simulator training: Randomized controlled trial
Scientific Title
Efficacy of transesophageal echocardiography simulator training: Randomized controlled trial
Scientific Title:Acronym
Efficacy of transesophageal echocardiography simulator training: Randomized controlled trial
Region
| Japan |
Condition
Condition
Novices in transesophageal echocardiography
Classification by specialty
| Cardiology | Anesthesiology | Cardiovascular surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the efficacy of a training using transesophageal echocardiography simulator for novices
compared with a traditional training of transesophageal echocardiography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Score of wrritten test and transesophageal echocardiography skill test using simulator
Key secondary outcomes
Participants' satisfaction of training program using a questionnaire.
Change in score of written test between before and after training.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Training method using transesophageal echocardiography simulator
Interventions/Control_2
Traditional and didactic training method of transesophageal echocardiography without simulator.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Doctors who have less knowledge and experiences of transesophageal echocardiography.
Key exclusion criteria
Participants with knowledge and experiences of transesophageal echocardiography.
Participants who are board certified in transesophageal echocardiography.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taeko Komuro |
Organization
Kameda General Hospital
Division name
Department of Anesthesiology
Zip code
Address
929, Higashicho, Kamogawashi, Chiba, Japan
TEL
0470922211
nyakki2010@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Jujo |
Organization
Kameda General Hospital
Division name
Department of Anesthesiology
Zip code
Address
929, Higashicho, Kamogawashi, Chiba, Japan
TEL
0470922211
Homepage URL
neo.j.j@live.jp
Sponsor or person
Institute
Department of Anesthesilogy, Kameda General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
亀田総合病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
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
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035816
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/02/27 | TEE simulator RCT研究計画書 .docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
