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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035507
Receipt No. R000040456
Scientific Title Assessment of skin contact pressure of a novel facemask for mask ventilation
Date of disclosure of the study information 2019/04/01
Last modified on 2020/03/14

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Basic information
Public title Assessment of skin contact pressure of a novel facemask for mask ventilation
Acronym Skin contact pressure of a novel facemask
Scientific Title Assessment of skin contact pressure of a novel facemask for mask ventilation
Scientific Title:Acronym Skin contact pressure of a novel facemask
Region
Japan

Condition
Condition A patient who receives general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of a novel facemask, QuadraLite, we will measure and compare the skin contact pressures for QuadraLite and conventional facemask
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin contact pressure of two types of facemasks for positive pressure mask ventilation will be measured and compared during the general anesthesia.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A novel facemask, QuadraLite, for generak anesthesia.
Interventions/Control_2 A conventional facemask for general anesthesia.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status 1 or 2, aged 20-65 years, who are scheduled to undergo general anesthesia will be selected.
Key exclusion criteria Exclusion criteria includes predicted difficulty in airway mamagement, obesity and skin disease on the face.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shigeki
Middle name
Last name Yamaguchi
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Zip code 321-0293
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Email takasusu@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Toshifumi
Middle name
Last name Takasusuki
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Zip code 321-0293
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Homepage URL
Email takasusu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
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 Dokkyo Medical University
Address 880 Kitakobayashi, Mibu, Tochigi , Japan
Tel 0282861111
Email takasusu@dokkyomed.ac.jp

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
2019 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 10 Day
Last modified on
2020 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040456

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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