UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035507 |
|---|---|
| Receipt number | 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 08:34:03 |
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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
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
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040456
