UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034093 |
|---|---|
| Receipt number | R000038869 |
| Scientific Title | Changes in ventilation conditions by two kinds of face masks |
| Date of disclosure of the study information | 2018/09/12 |
| Last modified on | 2018/09/11 16:04:43 |
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Basic information
Public title
Changes in ventilation conditions by two kinds of face masks
Acronym
Changes in ventilation conditions by two kinds of face masks
Scientific Title
Changes in ventilation conditions by two kinds of face masks
Scientific Title:Acronym
Changes in ventilation conditions by two kinds of face masks
Region
| Japan |
Condition
Condition
Oral surgical operation under general anesthesia
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are various kinds of ventilation masks, and regarding differences in the amount of evacuation by two kinds of general-purpose masks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Difference in ventilation after successful muscle relaxant
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Treatment plan under general anesthesia
Key exclusion criteria
Moderate or higher circulatory complications, respiratory complications
Extremely mask ventilation difficulties
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Tsukamoto |
Organization
Kyushu University Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1-1 Higashidori Higashi ku Fukuoka city
TEL
092-6412-6480
tsukamoto@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Tsukamoto |
Organization
Kyushu University Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1-1 Higashidori Higashi ku Fukuoka city
TEL
092-6412-6480
Homepage URL
tsukamoto@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 12 | 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
| 2018 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2018 | Year | 09 | Month | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038869
