UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046067 |
|---|---|
| Receipt number | R000052575 |
| Scientific Title | Relationship between cardiac function and position |
| Date of disclosure of the study information | 2021/11/13 |
| Last modified on | 2021/11/13 16:25:58 |
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Basic information
Public title
Relationship between cardiac function and position
Acronym
Relationship between cardiac function and position
Scientific Title
Relationship between cardiac function and position
Scientific Title:Acronym
Relationship between cardiac function and position
Region
| Japan |
Condition
Condition
volunteer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, laparoscopic surgery has been increasing steadily. In particular, the lower gastrointestinal tract and urological Da Vinci surgery are organs in the pelvis, so it is necessary to take a remarkable low head position to secure the intraoperative visual field. It has been reported that these positions have a considerable effect on the cardiovascular system, and the left ventricular ejection fraction (LVEF) is reduced by 20% 1). Especially in patients with heart disease, the change is expected to be remarkable. Therefore, we decided to investigate and study how much the myocardial contractile force and diastolic ability of the left and right heart systems change depending on the low head position in healthy human volunteers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For 30 volunteers, the lateral contraction ability and diastolic ability are first measured by transthoracic echocardiography in the horizontal position.
The contractility is the ejection fraction (EF), fractionation fraction (% FS), and the mitral valve and tricuspid annulus systolic movement distance, which are said to be easy to measure and correlate well with EF. Measure (MAPSE, TAPSE) 2). For diastolic function, measure E / A and E / e'both left heart and right heart system 3). After that, keep the head low at 30 degrees for 7.5 minutes 4) and record the changes in contractile ability and diastolic ability. In addition, blood pressure and heart rate in the horizontal and low head positions are recorded as hemodynamics.
The purpose of this study is how the general measurements EF,% FS, E / A correlate with the relatively new MAPSE, TAPSE, E / e'. And it is to examine how these values change depending on the low head.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Health volunteer
Key exclusion criteria
without approval
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MITSUHARU |
| Middle name | |
| Last name | KODAKA |
Organization
TOYO WOMEN'S MEDICAL UNIVERSITY
Division name
Medical center east, anesthesiology
Zip code
116-8567
Address
2-1-10 Nishiogu Arakawa-ku, 116-8567 Tokyo
TEL
0338101111
kmkodaka@cb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | MITSUHARU |
| Middle name | |
| Last name | KODAKA |
Organization
Tokyo women's medical university
Division name
Medical center east, anesthesiology
Zip code
116-8567
Address
2-1-10 Nishiogu Arakawa-ku, 116-8567 Tokyo
TEL
0338101111
Homepage URL
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
TOKYO WOMEN'S MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
TOKYO WOMEN'S MEDICAL UNIVERSITY
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
TOKYO WOMEN'S MEDICAL UNIVERSITY
Address
2-1-10 Nishiogu Arakawa-ku, 116-8567 Tokyo
Tel
0338101111
kmkodaka@cb3.so-net.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
5427
Org. issuing International ID_1
IRB of TWMU
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
OBSERVATIONAL TRIAL
Management information
Registered date
| 2021 | Year | 11 | Month | 13 | Day |
Last modified on
| 2021 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052575
