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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030565
Receipt No. R000033898
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
Date of disclosure of the study information 2017/12/26
Last modified on 2017/12/26

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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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 26 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
2017 Year 12 Month 26 Day
Last modified on
2017 Year 12 Month 26 Day


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

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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