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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023307
Receipt No. 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

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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
Email 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
Email mind_koma@yahoo.co.jp

Sponsor
Institute Fujita Health University School of Medicine, Department of Anesthesiology and Critical Care Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024258

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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