UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023307 |
|---|---|
| Receipt number | R000024258 |
| Scientific Title | A preliminary study nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask in healthy volunteers |
| Date of disclosure of the study information | 2016/07/23 |
| Last modified on | 2017/04/17 12:54:35 |
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Basic information
Public title
A preliminary study nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask in healthy volunteers
Acronym
Nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask
Scientific Title
A preliminary study nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask in healthy volunteers
Scientific Title:Acronym
Nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During nasal high flow therapy, we consider a CPAP effect can be obtained by mimicking a closed-mouth state using a surgical face mask even in the mouth open.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in the nasopharyngeal pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
No oxygen therapy(in the mouth open)
Interventions/Control_2
Nasal high flow(in the mouth open)
Interventions/Control_3
Nasal high flow(in the mouth open) plus surgical face mask
Interventions/Control_4
Nasal high flow(in the mouth close)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
nurses who work in ICU at Fujita Health University School of Medicine
Key exclusion criteria
(1)state treating a respiratory disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Nishida |
Organization
Fujita Health University School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-9008
nishida@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Komatsu |
Organization
Fujita Health University School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-9008
Homepage URL
mind_koma@yahoo.co.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Anesthesiology and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 23 | 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
| 2016 | Year | 07 | Month | 23 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024258
