UMIN-CTR Clinical Trial

Basic information
Public title	The Efficacy of Two Oxygen Therapy Devices(Nasal Cannula vs. Simple Mask) for Preventing Hypoxemia after General Anesthesia:A Randomized Controlled Non-Inferiority Trial
Acronym	The Efficacy of Two Oxygen Therapy Devices(Nasal Cannula vs. Simple Mask) for Preventing Hypoxemia after General Anesthesia
Scientific Title	The Efficacy of Two Oxygen Therapy Devices(Nasal Cannula vs. Simple Mask) for Preventing Hypoxemia after General Anesthesia:A Randomized Controlled Non-Inferiority Trial
Scientific Title:Acronym	The Efficacy of Two Oxygen Therapy Devices(Nasal Cannula vs. Simple Mask) for Preventing Hypoxemia after General Anesthesia
Region	Japan

Condition
Condition	Dental treatment
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of oxygenation and comfort between Nasal cannula oxygen and face mask oxygen.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Questionnaire (STAI, VAS of postoperative pain, nausea and comfort)
Key secondary outcomes	Comparison of amount of change in oxygen saturation between before and after general anesthesia.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We get a questionnaire (STAI) before surgery. Oxygen is administrated via a nasal cannula at 3L/min for 1 hour after general anesthesia. Monitoring is performed for 2 hours after general anesthesia, and at the completion of monitoring, a questionnaire (postoperative pain / nausea, comfort VAS) is acquired.
Interventions/Control_2	We get a questionnaire (STAI) before surgery. Oxygen is administrated via a simple mask at 5L/min for 1 hour after general anesthesia. Monitoring is performed for 2 hours after general anesthesia, and at the completion of monitoring, a questionnaire (postoperative pain / nausea, comfort VAS) is acquired.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients awaiting surgery under general anesthesia/ Provided written informed consent to undergo the procedure/ be able to communicate in Japanese/ ASA Physical Status 1 or 2.
Key exclusion criteria	Exclusion criteria includes patients who are undergoing oxygen therapy before surgery/ scheduled to have indwelling nasogastric/ scheduled to treat the maxilla sinus and nasal cavity/ judged to unsuitable to this study.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kawamoto Yui
Organization	Showa University Dental Hospital
Division name	Department of Perioperative Medicine, Division of Anesthesiology
Zip code
Address	2-1-1, Kitasenzoku, oota-ku, Tokyo
TEL	03(3787)1151
Email	yui0203@dent.showa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kawamoto Yui
Organization	Showa University Dental Hospital
Division name	Department of Perioperative Medicine, Division of Anesthesiology
Zip code
Address	2-1-1, Kitasenzoku, oota-ku, Tokyo
TEL	03(3787)1151
Homepage URL
Email	yui0203@dent.showa-u.ac.jp

Sponsor
Institute	Department of Perioperative Medicine, Division of Anesthesiology
Institute
Department

Funding Source
Organization	Department of Perioperative Medicine, Division of Anesthesiology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	昭和大学歯科病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 26 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	Terminated
Date of protocol fixation	2017 Year 12 Month 01 Day
Date of IRB	2017 Year 12 Month 26 Day
Anticipated trial start date	2017 Year 12 Month 26 Day
Last follow-up date	2018 Year 03 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	2017 Year 12 Month 26 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033898