UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031427
Receipt No. 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

* 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 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
Email 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
Email neo.j.j@live.jp

Sponsor
Institute Department of Anesthesilogy, Kameda General Hospital
Institute
Department

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
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 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
URL(English) https://upload.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


Contact us.