UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042751
Receipt number R000048793
Scientific Title A fraction of inspired oxygen in surgical patients wearing an oxygen mask over a nonmedical face mask.
Date of disclosure of the study information 2020/12/15
Last modified on 2022/06/16 11:02:02

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Basic information

Public title

A fraction of inspired oxygen in surgical patients wearing an oxygen mask over a nonmedical face mask.

Acronym

A fraction of inspired oxygen in surgical patients wearing an oxygen mask over a nonmedical face mask.

Scientific Title

A fraction of inspired oxygen in surgical patients wearing an oxygen mask over a nonmedical face mask.

Scientific Title:Acronym

A fraction of inspired oxygen in surgical patients wearing an oxygen mask over a nonmedical face mask.

Region

Japan


Condition

Condition

elective surgical patients

Classification by specialty

Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate a difference in a surgical patient`s fraction of inspired oxygen when oxygen is administered by an oxygen mask directly or wearing a nonmedical mask.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

fraction inspired oxygen

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

elective surgical patients

Key exclusion criteria

additional oxygen is contraindicated

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Hitoshi
Middle name
Last name Sato

Organization

Yokohama City University Medical Center

Division name

Department of Anesthesiology

Zip code

232-0024

Address

4-57 Urafunechou Minamiku Yokohama

TEL

045-261-5656

Email

sjinkun@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Hitoshi
Middle name
Last name Sato

Organization

Yokohama City University Medical Center

Division name

Department of Anesthesiology

Zip code

232-0024

Address

4-57 Urafunechou Minamiku Yokohama

TEL

045-261-5656

Homepage URL


Email

sjinkun@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University Medical Center

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

Yokohama City University Medical Center

Address

4-57 Urafunechou Minamiku Yokohama

Tel

045-261-5656

Email

sjinkun@yokohama-cu.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



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 15 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

99

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

Main results already published

Date of protocol fixation

2020 Year 12 Month 14 Day

Date of IRB

2020 Year 10 Month 23 Day

Anticipated trial start date

2020 Year 12 Month 15 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

2022 Year 04 Month 08 Day


Other

Other related information

We investigate a difference in a surgical patient`s fraction of inspired oxygen when oxygen is administered by an oxygen mask directly or wearing a nonmedical mask.


Management information

Registered date

2020 Year 12 Month 14 Day

Last modified on

2022 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name