UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023155
Receipt number R000026677
Scientific Title Does position of general anesthesia influence regional saturation of oxygen (rSO2)?
Date of disclosure of the study information 2016/07/13
Last modified on 2021/07/02 22:27:47

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Basic information

Public title

Does position of general anesthesia influence regional saturation of oxygen (rSO2)?

Acronym

Influence of patient's position on rSO2

Scientific Title

Does position of general anesthesia influence regional saturation of oxygen (rSO2)?

Scientific Title:Acronym

Influence of patient's position on rSO2

Region

Japan


Condition

Condition

robotics assisted laparoscopic prostatectomy, renal transplantation, breast cancer, shoulder arthroscopic surgery, robotics assisted lung cancer and mediastinal tumor

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We measure rSO2 when patient's position change from supine to beach chair position, head down position or lateral position and return to supine.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

rSO2 by change of patient's position during operation

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are scheduled robotics assisted laparoscopic prostatectomy and lung surgery, renal transplantation, operation of breast cancer, shoulder arthroscopic surgery, or thoracic surgery, and are written informed consent

Key exclusion criteria

cerebrovascular disease
stenosis of carotid artery

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Ozaki

Organization

Tokyo Women's Medical University

Division name

Anesthesiology

Zip code

162-8666

Address

8-1Kawadacho Shinjuku-ku Tokyo

TEL

03-3353-8111

Email

mozaki@anes.twmu.ac.jp


Public contact

Name of contact person

1st name Tomoko
Middle name
Last name Fukada

Organization

Tokyo Women's Medical University

Division name

Anesthesiology

Zip code

162-8666

Address

8-1Kawadacho Shinjuku-ku Tokyo

TEL

03-3353-8111

Homepage URL


Email

fukada.tomoko@twmu.ac.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

Self funding

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

8-1Kawadacho Shinjuku-ku Tokyo

Tel

03-3353-8111

Email

@twmu.ac.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

東京女子医科大学(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 07 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

2021 Year 06 Month 16 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 05 Month 23 Day

Date of IRB

2019 Year 03 Month 22 Day

Anticipated trial start date

2016 Year 06 Month 04 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We measure but rSO2 not SpO2 and BP during change patient's position.


Management information

Registered date

2016 Year 07 Month 13 Day

Last modified on

2021 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026677


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name