UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035165 |
|---|---|
| Receipt number | R000040018 |
| Scientific Title | Comparison of deep breathing and tidal volume breathing preoxygenation techniques with the Oxygen Reserve Index (ORI) in volunteers. |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2022/04/14 09:22:26 |
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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
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
akanaya@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040018
