UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007952 |
|---|---|
| Receipt number | R000009338 |
| Scientific Title | The evaluation of the mask ventilation by the newly developed mask |
| Date of disclosure of the study information | 2012/05/15 |
| Last modified on | 2013/05/16 16:25:38 |
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Basic information
Public title
The evaluation of the mask ventilation by the newly developed mask
Acronym
The evaluation of the mask ventilation by the newly developed mask
Scientific Title
The evaluation of the mask ventilation by the newly developed mask
Scientific Title:Acronym
The evaluation of the mask ventilation by the newly developed mask
Region
| Japan |
Condition
Condition
Patients that undergo elective surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The mask ventilation with newly developed mask is more useful than that with classical mask.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
end-tidal CO2
Key secondary outcomes
pressure between mask and face
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Group with mask ventilation using classical mask holding by EC methods.
Interventions/Control_2
Group with mask ventilation using classical mask holding by GL methods.
Interventions/Control_3
Group with mask ventilation using newly developed mask holding by GL methods.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective surgery with general anesthesia
Key exclusion criteria
1 Patients that difficult mask ventilation is expected.
2 Patients with cardiovascular complications such as arrhythmia, abnormal ECG prior to surgery.
3 Patients with respiratory complications such as hypoxemia.
4 Patients that aspiration is expected.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Tanaka |
Organization
Tokushima University
Division name
Anesthesiology
Zip code
Address
3-18-15 Kuramoto, Tokushima, Tokushima
TEL
088-633-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Tanaka |
Organization
Tokushima University
Division name
Anesthesiology
Zip code
Address
3-18-15 Kuramoto, Tokushima, Tokushima
TEL
Homepage URL
Sponsor or person
Institute
Dpartment of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 05 | Month | 15 | Day |
Last modified on
| 2013 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009338
