UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Acronym	Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Scientific Title	Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Scientific Title:Acronym	Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Region	Japan

Condition
Condition	Patient undergoing elective surgery under general anesthesia
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparison of one-handed and two-handed mask ventilation after induction of general anesthesia by Sp02 and Oxygen Reserve Index(ORI).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oxygen Reserve Index 2 minutes after the start of each mask ventilation method
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	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	two minute of one-handed mask ventilation
Interventions/Control_2	two minute of two-handed mask ventilation
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	ASA-PS 1,2 Patients undergoing elective surgery under general anesthesia
Key exclusion criteria	Unexpected difficult airway
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Miyake
Organization	Japan Self Defense Force Hospital Yokosuka
Division name	Department of Anesthesiology
Zip code	2370071
Address	1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL	046-823-0270
Email	y.miyake0520@gmail.com

Public contact
Name of contact person	1st name Yu Middle name Last name Miyake
Organization	Japan Self Defense Force Hospital Yokosuka
Division name	Department of Anesthesiology
Zip code	2370071
Address	1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL	046-823-0270
Homepage URL
Email	y.miyake0520@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	Japan Self Defense Force Hospital Yokosuka
Address	1766-1 Tauraminatocho, Yokosuka, Kanagawa
Tel	046-823-0270
Email	doc33058@ndmc.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	2021 Year 06 Month 14 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	Open public recruiting
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 10 Month 20 Day
Anticipated trial start date	2020 Year 12 Month 01 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

Management information
Registered date	2021 Year 06 Month 14 Day
Last modified on	2021 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050871