UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036378 |
|---|---|
| Receipt number | R000041424 |
| Scientific Title | Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2024/04/04 10:54:29 |
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Basic information
Public title
Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease
Acronym
Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease
Scientific Title
Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease
Scientific Title:Acronym
Study on the effect of High-Flow Nasal Cannula on exercise duration of patients with interstitial lung disease
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of High-flow nasal cannula on exercise duration in patients with interstitial lung disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Endurance time of bicycle ergometer according to High-flow nasal cannula setting condition
Key secondary outcomes
Subjective dyspnea while performing a bicycle ergometer with High-flow nasal cannula settings
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Room air
Interventions/Control_2
High-flow nasal cannula(FiO2 0.21, Flow 40L/min)
Interventions/Control_3
High-flow nasal cannula(FiO2 0.6, Flow 40L/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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Patients with stable interstitial lung disease who are hospitalized for the purpose of introducing steroids, pirfenidone and nintedanib
2, Age at the time of consent acquisition is over 40 years old and under 80 years old
3, Informed consent can be obtained in writing from the person
Key exclusion criteria
1, Having collagen disease, neuromuscular disease, or orthopedic disease that may affect exercise tolerance assessment at enrollment
2, Requires antiarrhythmic treatment
3, Clinically complicated with severe pulmonary antihypertension
4, Researcher decides that it is not appropriate to register for this exam
5, Patients with malignant tumors whose recurrence has not been confirmed for over 3 years
6, Home oxygen therapy introduction patient
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yanagita |
| Middle name | |
| Last name | Yorihide |
Organization
Seirei Mikatahara General Hospital
Division name
Dept. of Rehabilitation
Zip code
433-8558
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
TEL
053-436-1251
dependonhero@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yanagita |
| Middle name | |
| Last name | Yorihide |
Organization
Seirei Mikatahara General Hospital
Division name
Dept. of Rehabilitation
Zip code
433-8558
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
TEL
053-436-1251
Homepage URL
dependonhero@yahoo.co.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital, Dept. of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Seirei Mikatahara General Hospital
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
Tel
053-436-1251
dependonhero@yahoo.co.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
聖隷三方原病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/resp.14684
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/resp.14684
Number of participants that the trial has enrolled
25
Results
Twenty-five participants were enrolled. The increase in exercise duration between the ROOM AIR and FLOW was 46.3 s, and the FLOW and FLOW + OXYGEN was 91.5 s. The percutaneous oxygen saturation (SpO2) at rest was significantly higher with the FLOW + OXYGEN setting than with the ROOM AIR and FLOW settings, and the difference persisted during exercise. At equivalent time points during exercise, the SpO2 with the FLOW setting was significantly higher than that with the ROOM AIR setting.
Results date posted
| 2024 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 22 | Day |
Baseline Characteristics
Stable patients diagnosed with ILD between 1 June 2019 and 31 December 2022 by respiratory physicians using clinical and imaging data were recruited before initiating the pulmonary rehabilitation program at Seirei Mikatahara General Hospital.
Participant flow
This was a three-treatment crossover study with an experimental design. Participants were randomly assigned to a sequence of three interventions involving different HFNC settings. All participants performed five exercise testing sessions over five consecutive days.
Adverse events
noting
Outcome measures
The exercise endurance time was the primary endpoint, defined as the time (in seconds) from the start to the end of the exercise load, excluding the warm-up. In previous studies, endurance time was the most effective exercise measure for IPF.
The SpO2, heart rate (HR), dyspnoea, and leg fatigue were measured during exercise using a cycle ergometer. The SpO2 and HR were continuously measured (WEP-5200; Nihon Kohden, Japan). During endurance exercise, we did not allow participants to see their own SpO2 and HR shown on the monitor screen. Dyspnoea and leg fatigue were assessed every minute using a Borg scale, with scores ranging from 0 to 10. Each of the Iso-time measurements, defined as the time at which the shortest test was completed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041424
