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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029707
Receipt No. R000033949
Scientific Title The assessment of tricuspid annulus fractional shortening for right ventricular contraction by using intraoperative transesophageal echocardiography
Date of disclosure of the study information 2017/10/30
Last modified on 2017/10/25

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Basic information
Public title The assessment of tricuspid annulus fractional shortening for right ventricular contraction by using intraoperative transesophageal echocardiography
Acronym The assessment of tricuspid annulus fractional shortening
Scientific Title The assessment of tricuspid annulus fractional shortening for right ventricular contraction by using intraoperative transesophageal echocardiography
Scientific Title:Acronym The assessment of tricuspid annulus fractional shortening
Region
Japan

Condition
Condition Patients who take cardiac surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the usefulness of tricuspid annulus fractional shortening (TAFS) as right ventricular contraction by using intraoperative transesophageal echocardiography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To measure TAFS by TEE and to compare with tricuspid annular plane systolic excursion(TAPSE) and systolic wave by TTE.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 transthoracic echocardiography
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Ptients who take cardiac surgery under general anesthesia
Key exclusion criteria Patients who don't insert transesophageal echo probe
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sawai Toshiyuki
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi Takatsuki Osaka
TEL 0726831221
Email ane026@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sawai Toshiyuki
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi Takatsuki Osaka
TEL 0726831221
Homepage URL
Email ane026@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2020 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 25 Day
Last modified on
2017 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033949

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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