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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023019
Receipt No. R000025003
Scientific Title Evaluation of head-rotation effect for mask ventilation in patients under general anesthesia.
Date of disclosure of the study information 2016/07/05
Last modified on 2016/08/31

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Basic information
Public title Evaluation of head-rotation effect for mask ventilation in patients under general anesthesia.
Acronym Mask ventilation efficacy by head rotation.
Scientific Title Evaluation of head-rotation effect for mask ventilation in patients under general anesthesia.
Scientific Title:Acronym Mask ventilation efficacy by head rotation.
Region
Japan

Condition
Condition Patients who undergo general anesthesia
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of head rotation effect for mask ventilation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mask ventilation profile
Key secondary outcomes Subjective difficult of mask ventilation

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Mask ventilation with head rotation to
Mask ventilation with normal status
Interventions/Control_2 Mask ventilation with normal status to
Mask ventilation with head rotation
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
75 years-old >=
Gender Female
Key inclusion criteria Patients who undergo general anesthesia
Key exclusion criteria Patients with mask ventilation difficulty
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuk city
TEL 072-696-2121
Email ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyasu Komasawa
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7Daigaku-machi, Takatsuki city
TEL 0726-84-6361
Homepage URL
Email ane078@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osake Medical College
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 05 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
Mask ventilation volume did not differ significantly by head rotation.
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 Completed
Date of protocol fixation
2016 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 10 Day
Last follow-up date
2016 Year 08 Month 30 Day
Date of closure to data entry
2016 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Subjective difficulty of mask ventilation by anesthesiologists did not differ significnatly.

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2016 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025003

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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