UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040144 |
|---|---|
| Receipt number | R000045717 |
| Scientific Title | Development of an easy-to-use cuff pressure management device for nurses |
| Date of disclosure of the study information | 2020/04/13 |
| Last modified on | 2020/04/13 15:47:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of an easy-to-use cuff pressure management device for nurses
Acronym
Development of an easy-to-use cuff pressure management device for nurses
Scientific Title
Development of an easy-to-use cuff pressure management device for nurses
Scientific Title:Acronym
Development of an easy-to-use cuff pressure management device for nurses
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the prototype cuff pressure management device has become easier for nurses to use
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Required time, State of task, subjective evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using an endotracheal tube inflator within 1 hour
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy person
Nurses or other healthcare professionals
Key exclusion criteria
Musculoskeletal disorder, exercised vigorously the day before,drank after 21:00 on the day before the test,stayed up all night
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kumi |
| Middle name | |
| Last name | OGA |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Universal Design Section
Zip code
421-1298
Address
2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan
TEL
054-278-3024
kumi1_oga@pref.shizuoka.lg.jp
Public contact
Name of contact person
| 1st name | Kumi |
| Middle name | |
| Last name | OGA |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Universal Design Section
Zip code
421-1298
Address
2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan
TEL
054-278-3024
Homepage URL
kumi1_oga@pref.shizuoka.lg.jp
Sponsor or person
Institute
Industrial Research Institute of Shizuoka Prefecture
Institute
Department
Personal name
Funding Source
Organization
Industrial Research Institute of Shizuoka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Industrial Research Institute of Shizuoka Prefecture
Address
2078 Makigaya Aoi-Ward Shizuoka-City Shizuoka-Pref. Japan
Tel
054-278-3024
kumi1_oga@pref.shizuoka.lg.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
| 2020 | Year | 04 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2020 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045717
