UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030565 |
|---|---|
| Receipt number | 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 | 2022/11/25 21:51:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yui0203@dent.showa-u.ac.jp
Sponsor or person
Institute
Department of Perioperative
Medicine, Division of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033898
