UMIN-CTR Clinical Trial

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	Randomized
Randomization unit	Individual
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 Ayana Middle name Last name Kanaya
Organization	National Defense Medical College
Division name	Department of Anesthesiology
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa, Saitama, JAPAN
TEL	04-2995-1214
Email	akanaya@ndmc.ac.jp

Public contact
Name of contact person	1st name Ayana Middle name Last name Kanaya
Organization	National Defense Medical College
Division name	Department of Anesthesiology
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa, Saitama, Japan
TEL	04-2995-1214
Homepage URL
Email	akanaya@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
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	National Defense Medical College
Address	3-2 Namiki, Tokorozawa, Saitama, Japan
Tel	04-2995-1214
Email	akanaya@ndmc.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	30-01
Org. issuing International ID_1	JSDF Hospital Yokosuka
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	防衛医科大学校病院(埼玉県) 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	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	25
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	It takes time to write a paper.
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	2018 Year 12 Month 10 Day
Date of IRB	2018 Year 11 Month 14 Day
Anticipated trial start date	2018 Year 12 Month 10 Day
Last follow-up date	2020 Year 11 Month 13 Day
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	2022 Year 04 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040018