UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A preliminary study nasopharyngeal pressure is increased by the concomitant use of a nasal high flow cannula with surgical face mask in healthy volunteers
Title of the study (Brief title)	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	Osamu Nishida
Organization	Fujita Health University School of Medicine
Division name	Department of Anesthesiology and Critical Care Medicine
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	Satoshi Komatsu
Organization	Fujita Health University School of Medicine
Division name	Department of Anesthesiology and Critical Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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