UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059588 |
|---|---|
| Receipt number | R000068151 |
| Scientific Title | Effects of Different Flow Rates in High-Flow Nasal Cannula Oxygen Therapy on Exercise Tolerance |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/30 08:52:11 |
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Basic information
Public title
Effects of Different Flow Rates in High-Flow Nasal Cannula Oxygen Therapy on Exercise Tolerance
Acronym
The Effect of Different HFNC Flow Rates on Exercise Tolerance
Scientific Title
Effects of Different Flow Rates in High-Flow Nasal Cannula Oxygen Therapy on Exercise Tolerance
Scientific Title:Acronym
The Effect of Different HFNC Flow Rates on Exercise Tolerance
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of different gas flow rates in HFNC therapy on exercise tolerance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise duration
Key secondary outcomes
1. Subjective dyspnea and lower limb fatigue: Before nasal cannula placement, before CPX, after warm-up, and every minute after exercise initiation
2. Ease of exhalation and inhalation, nasal cannula discomfort (assessed using Visual Analog Scale): Before and after the experiment
3. Vital signs (SpO2, pulse rate, respiratory rate): Before nasal cannula placement, before CPX, after warm-up, every minute after exercise load initiation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High-Flow Nasal Cannula Oxygen Therapy Settings: FiO2 0.21, Flow 30 L/min
Interventions/Control_2
High-Flow Nasal Cannula Oxygen Therapy Settings: FiO2 0.21, Flow 45 L/min
Interventions/Control_3
High-Flow Nasal Cannula Oxygen Therapy Settings: FiO2 0.21, Flow 60 L/min
Interventions/Control_4
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
Young healthy males who understood the purpose of this study and provided informed consent
Key exclusion criteria
Individuals for whom cardiopulmonary exercise testing is difficult due to musculoskeletal disorders or lower limb pain
Individuals with a history of respiratory or cardiovascular disease
Individuals who have smoked within the past month
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yorihide |
| Middle name | |
| Last name | Yanagita |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7967
y-yanagita@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yorihide |
| Middle name | |
| Last name | Yanagita |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7967
Homepage URL
y-yanagita@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Sciences Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, Japan
Tel
095-819-7967
y-yanagita@nagasaki-u.ac.jp
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
| 2025 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068151
