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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028483
Receipt No. R000031067
Scientific Title Accuracy of right ventricular ejection fraction and volume measured by three-dimensional transesophageal echocardiography.
Date of disclosure of the study information 2017/08/01
Last modified on 2017/08/01

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Basic information
Public title Accuracy of right ventricular ejection fraction and volume measured by three-dimensional
transesophageal echocardiography.
Acronym Accuracy of right ventricular ejection fraction and volume measured by three-dimensional
transesophageal echocardiography.
Scientific Title Accuracy of right ventricular ejection fraction and volume measured by three-dimensional
transesophageal echocardiography.
Scientific Title:Acronym Accuracy of right ventricular ejection fraction and volume measured by three-dimensional
transesophageal echocardiography.
Region
Japan

Condition
Condition Adult Heart Disease
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the accuracy of right ventricular
ejection fraction and volume obtained from three-demensional transesophageal echocardiography.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Right ventricuar ejection fraction and end-diastolic volume and end-systolic volume
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who needed transesophageal echocardiography and pulmonary artery catheter as intraoperative monitoring during their cardiac surgery or non-cardiac surgery
Key exclusion criteria Patients undergoing emergency surgery, patients with past history of intracardiac surgery and arrhythmia.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KIICHI YANO
Organization Asahikawa Medical University
Division name Department of Anesthesiology&Critical care
Zip code
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166-65-2111
Email yanoki39@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name KIICHI YANO
Organization Asahikawa Medical University
Division name Department of Anesthesiology&Critical care
Zip code
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166-65-2111
Homepage URL
Email yanoki39@gmail.com

Sponsor
Institute Asahikawa Medical University
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 08 Month 01 Day
Last modified on
2017 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031067

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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