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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007952
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Dpartment of Anesthesiology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009338

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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