UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026346 |
|---|---|
| Receipt number | 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 | 2019/09/02 12:51:19 |
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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
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
ryoheikunn@msf.biglobe.ne.jp
Sponsor or person
Institute
Hirakata Kohsai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030229
