UMIN-CTR Clinical Trial

Basic information
Public title	Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)
Acronym	Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)
Scientific Title	Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)
Scientific Title:Acronym	Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)
Region	Japan

Condition
Condition	Volunteers
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The physiological mechanisms of the constant-flow and constant-pressure models of the Nasal High-flow Oxygen Therapy System are studied.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The physiological mechanisms of the constant-flow and constant-pressure models of NHF-OTS study in 10 volunteers by esophageal balloon methods, electrical impedance method, and the forced oscillation technique (FOT).
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	6
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Steady air Atom Medical,Japan 30L/min 5minutes
Interventions/Control_2	Steady air Atom Medical,Japan 50L/min 5minutes
Interventions/Control_3	AIRVO2, Optiflow Fisher&Paykel, New Zealand 30L/min 5minutes
Interventions/Control_4	AIRVO2, Optiflow Fisher&Paykel, New Zealand 50L/min 5minutes
Interventions/Control_5	Vivo 50 Breas Medical AB, Sweden PMH7000plus Pacific Medico Co. Ltd.,Japan nasal cannula No.3Pacific Medico Co. Ltd.,Japan 30L/min 5minutes
Interventions/Control_6	Vivo 50 Breas Medical AB, Sweden PMH7000plus Pacific Medico Co. Ltd.,Japan nasal cannula No.3Pacific Medico Co. Ltd.,Japan 50L/min 5minutes
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	45 years-old >=
Gender	Male
Key inclusion criteria	Ten healthy adult Japanese men are enrolled in the study.
Key exclusion criteria	Respiratory dysfunction
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Miyuki Okuda
Organization	Hirakata Kohsai Hospital
Division name	Respiratory medicine
Zip code
Address	1-2-1-,Fujisakahigashimachi, Hirakata
TEL	072-858-8233
Email	ryoheikunn@msf.biglobe.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Miyuki Okuda
Organization	Hirakata Kohsai Hospital
Division name	Respiratory medicine
Zip code
Address	1-2-1-,Fujisakahigashimachi, Hirakata
TEL	072-858-8233
Homepage URL
Email	ryoheikunn@msf.biglobe.ne.jp

Sponsor
Institute	Hirakata Kohsai Hospital
Institute
Department

Funding Source
Organization	Hirakata Kohsai Hospital
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	2017 Year 03 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	Main results already published
Date of protocol fixation	2017 Year 03 Month 01 Day
Date of IRB	2017 Year 02 Month 25 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry	2018 Year 03 Month 01 Day
Date trial data considered complete	2018 Year 03 Month 01 Day
Date analysis concluded	2018 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 01 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030229