UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028483 |
|---|---|
| Receipt number | 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 | 2020/02/04 13:44:56 |
* 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
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 | KIICHI |
| Middle name | |
| Last name | YANO |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology&Critical care
Zip code
0788510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-65-2111
yanoki39@gmail.com
Public contact
Name of contact person
| 1st name | KIICHI |
| Middle name | |
| Last name | YANO |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology&Critical care
Zip code
0788510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-65-2111
Homepage URL
yanoki39@gmail.com
Sponsor or person
Institute
Asahikawa Medical University
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
Department of Anesthesiology&Critical care, Asahikawa Medical University
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
Tel
0166-65-2111
yanoki39@gmail.com
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031067
