UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037728
Receipt number R000043030
Scientific Title Evaluation of the changing circulating blood volume by the transthoracic echocardiography at the Concord position.
Date of disclosure of the study information 2019/08/19
Last modified on 2021/08/25 15:57:07

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Basic information

Public title

Evaluation of the changing circulating blood volume by the transthoracic echocardiography at the Concord position.

Acronym

Evaluation of the changing circulating blood volume by the transthoracic echocardiography at the Concord position.

Scientific Title

Evaluation of the changing circulating blood volume by the transthoracic echocardiography at the Concord position.

Scientific Title:Acronym

Evaluation of the changing circulating blood volume by the transthoracic echocardiography at the Concord position.

Region

Japan


Condition

Condition

Volunteer

Classification by specialty

Anesthesiology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It used to be reported about the changing cirlulating blood volume by using the transthoracic echocardiography at the spine and lateral position. We evaluate about the changing cirlulating blood volume by using the transthoracic echocardiography at the Concord position.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ejection Fraction

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

Other

Interventions/Control_1

Position of Concord postion

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

10 years-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

Volunteer

Key exclusion criteria

None

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yukako
Middle name
Last name Abukawa

Organization

Tokyo Jikei University

Division name

Anesthesia

Zip code

1058461

Address

3-25-8 Nishishinnbashi Minatoku Tokyo

TEL

0334331111

Email

yukakoabukawasandy@yahoo.co.jp


Public contact

Name of contact person

1st name Yukako
Middle name
Last name Abukawa

Organization

Tokyo Jikei University

Division name

Anesthesia

Zip code

1058461

Address

3-25-8 Nishishinnbashi Minatoku Tokyo

TEL

0334331111

Homepage URL


Email

yukakoabukawasandy@yahoo.co.jp


Sponsor or person

Institute

Tokyo Jikei University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Jikei 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 Jikei University

Address

3-25-8 Nishishinnbashi Mitanoku Tokyo

Tel

0334331111

Email

yukakoabukawasady@yahoo.co.jp


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

2019 Year 08 Month 19 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

5

Results

Ejection Fraction tend to decrease at the Concord position. Even if the volunteer turned back from the Concord position to the supine positon,ejection fraction continued to decrease. And Heart rate was going up at the Concord position. Also SpO2 was decrease slightly. But the blood pressure

Results date posted

2019 Year 08 Month 19 Day

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

2018 Year 09 Month 28 Day

Date of IRB

2019 Year 03 Month 19 Day

Anticipated trial start date

2019 Year 05 Month 18 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 19 Day

Last modified on

2021 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name