UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017760
Receipt number R000020493
Scientific Title Study of influence factors that affects the brain oxygen saturation during open-heart surgery
Date of disclosure of the study information 2015/06/02
Last modified on 2018/11/27 08:40:06

* 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

Study of influence factors that affects the brain oxygen saturation during open-heart surgery

Acronym

Study of influence factors that affects the brain oxygen saturation during open-heart surgery

Scientific Title

Study of influence factors that affects the brain oxygen saturation during open-heart surgery

Scientific Title:Acronym

Study of influence factors that affects the brain oxygen saturation during open-heart surgery

Region

Japan


Condition

Condition

adult patients undergoing open-heart surgery

Classification by specialty

Cardiovascular surgery Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we designed a study using near-infrared spectroscopy and visible spectroscopy to assess how skin blood flow or hemodilution influences brain oxygen saturation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

brain oxygen saturation, skin oxygen saturation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

the brain oxygen saturation monitor
NIRO-200NX

Interventions/Control_2

the brain oxygen saturation monitor
INVOS5100C

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


Not applicable

Gender

Male and Female

Key inclusion criteria

adult patients undergoing open-heart surgery in Juntendo University Hospital

Key exclusion criteria

patient with cerebrovascular disorder

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Matsushita

Organization

Juntendo University Faculty of Medicine

Division name

Cardiovascular Surgery

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

saty-m@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Matsushita

Organization

Juntendo University Faculty of Medicine

Division name

Cardiovascular Surgery

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

saty-m@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Juntendo University, Faculty of Medicine, Department of Cardiovascular Surgery

Organization

Division

Category of Funding Organization

Self funding

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

順天堂大学医学部附属順天堂医院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 01 Day

Last modified on

2018 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name