UMIN-CTR Clinical Trial

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
Email	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
Email	kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute	TOKYO WOMEN'S MEDICAL UNIVERSITY
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052575