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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026346
Receipt No. R000030229
Scientific Title Intrathoracic pressure measurement during Nasal High-flow Oxygen Therapy System (NHF-OTS)
Date of disclosure of the study information 2017/03/01
Last modified on 2018/03/02

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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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
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
2018 Year 03 Month 02 Day


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

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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