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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035324
Receipt No. R000040247
Scientific Title Determination of postoperative oxygen dose based on the Oxygen reserve index (ORi)
Date of disclosure of the study information 2019/02/15
Last modified on 2018/12/20

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Basic information
Public title Determination of postoperative oxygen dose
based on the Oxygen reserve index (ORi)
Acronym ORi and postoperative oxygen
Scientific Title Determination of postoperative oxygen dose
based on the Oxygen reserve index (ORi)
Scientific Title:Acronym ORi and postoperative oxygen
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Anesthesiology Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessing whether the extent of hyperoxia and oxygen consumption can be reduced by
regulating the postoperative supplemental
oxygen dose based on ORi
Basic objectives2 Others
Basic objectives -Others In comparison with the conservative treatment, the same extent of postoperative hypoxia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A low level of hyperoxia and oxygen
consumption by the reduced supplemental oxygen dose determined based on ORi
Key secondary outcomes The same extent of postoperative hypoxia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 decreasing the postoperative supplemental oxygen dose
Interventions/Control_2 fixed dose of postoperative oxygen
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
Key inclusion criteria ASA-PS 1,2
Key exclusion criteria Cardiovascular diseases
Respiratory diseases
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumagai Motoi
Organization Iwate Medical University Hospital
Division name Department of Anaesthesiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, Japan
TEL +81-19-651-5111
Email bear@kxd.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumagai Motoi
Organization Iwate Medical University Hospital
Division name Department of Anaesthesiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, Japan
TEL +81-19-651-5110(8153)
Homepage URL
Email bear@kxd.biglobe.ne.jp

Sponsor
Institute Iwate Medical University Hospital
Institute
Department

Funding Source
Organization Iwate Medical University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 15 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
2018 Year 12 Month 20 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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