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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035165
Receipt No. R000040018
Scientific Title Comparison of deep breathing and tidal volume breathing preoxygenation techniques with the Oxygen Reserve Index (ORI) in volunteers.
Date of disclosure of the study information 2018/12/10
Last modified on 2018/12/07

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Basic information
Public title Comparison of deep breathing and tidal volume breathing preoxygenation techniques with the Oxygen Reserve Index (ORI) in volunteers.
Acronym Comparison of deep breathing and tidal volume breathing preoxygenation techniques with the Oxygen Reserve Index (ORI) in volunteers.
Scientific Title Comparison of deep breathing and tidal volume breathing preoxygenation techniques with the Oxygen Reserve Index (ORI) in volunteers.
Scientific Title:Acronym Comparison of deep breathing and tidal volume breathing preoxygenation techniques with the Oxygen Reserve Index (ORI) in volunteers.
Region
Japan

Condition
Condition None
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of deep breathing and tidal volume breathing preoxygenation techniques using the Oxygen Reserve Index (ORI) in volunteers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time from holding breathing to become 0 level ORi.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 tidal volume breathing 3 min
Interventions/Control_2 deep breathing 30 sec
Interventions/Control_3 deep breathing 60 sec
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
40 years-old >=
Gender Male
Key inclusion criteria ASA-PS 1,2
Key exclusion criteria Cardiovascular diseases
Respiratory diseases
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanaya Ayana
Organization Japan Self Defense Force Hospital Yokosuka
Division name Department of Anesthesiology
Zip code
Address 1766-1 Taura-Minatocho, Yokosuka, Kanagawa JAPAN
TEL 046-823-0270
Email ayanakanaya0813@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kanaya Ayana
Organization Japan Self Defense Force Hospital Yokosuka
Division name Department of Anesthesiology
Zip code
Address 1766-1 Taura-Minatocho, Yokosuka, Kanagawa JAPAN
TEL 046-823-0270
Homepage URL
Email ayanakanaya0813@gmail.com

Sponsor
Institute Japan Self Defense Force Hospital Yokosuka
Institute
Department

Funding Source
Organization Japan Self Defense Force Hospital Yokosuka
Organization
Division
Category of Funding Organization Japanese Governmental office
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 自衛隊横須賀病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 10 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 10 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 07 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040018

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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