UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021901 |
|---|---|
| Receipt number | R000025256 |
| Scientific Title | Effect of high-flow nasal cannula therapy on exercise tolerance in patients with stable interstitial lung disease |
| Date of disclosure of the study information | 2016/04/13 |
| Last modified on | 2017/10/18 13:13:29 |
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Basic information
Public title
Effect of high-flow nasal cannula therapy on exercise tolerance in patients with stable interstitial lung disease
Acronym
High-flow nasal cannula therapy for stable interstitial lung disease
Scientific Title
Effect of high-flow nasal cannula therapy on exercise tolerance in patients with stable interstitial lung disease
Scientific Title:Acronym
High-flow nasal cannula therapy for stable interstitial lung disease
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a prospective, randomized crossover study for evaluation the efficacy and safety of high-flow nasal cannula therapy in patients with interstitial lung disease who have oxygen desaturation during exertion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Endurance exercise time
Key secondary outcomes
1. Dyspnea intensity on exertion
(modified Borg scale)
2. Desaturation during exertion(SpO2)
3. Maximum heart rate during exertion
4. Patient comfort during exertion
(NRS scale)
5. Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Arm A
Symptom limited incremental exercise tests were performed on electrically braked cycloergometer with room air or each oxygen flow at rest. On the following day, using a randomized, crossover protocol, two endurance studies were performed. The endurance study work-load was set at 80 % of the maximum work-load achieved during the prior incremental study.
First day: Endurance exercise test with Venturi mask (FiO2 0.5).
Second day: Endurance exercise test with high-flow nasal cannula therapy (50L/min, FiO2 0.5).
Interventions/Control_2
Arm B
Symptom limited incremental exercise tests were performed on electrically braked cycloergometer with room air or each oxygen flow at rest. On the following day, using a randomized, crossover protocol, two endurance studies were performed. The endurance study work-load was set at 80 % of the maximum work-load achieved during the prior incremental study.
First day: Endurance exercise test with high-flow nasal cannula therapy (50L/min, FiO2 0.5).
Second day: Endurance exercise test with Venturi mask (FiO2 0.5).
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with stable interstitial lung disease who have oxygen desaturation (SpO2 lower than 88%) during treadmill exercise tolerance test on room air or each oxygen flow at rest.
2. Patients who agree to participate in the study with the written informed consent.
Key exclusion criteria
1.Patients with obstructive pulmonary disease (FEV1/FVC lower than 0.7)
2.Patients with pneumothorax and/or pneumomediastinum
3.Patients with unstable diseases or the history of acute exacerbation within the last 1 month.
4.Patients with diseases affecting the outcome who regarded as inadequate for the study by the investigators.
5.Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
6.Any other patients who are regarded as inadequate for the study enrollment by the investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Taniguchi |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
Address
160 Nishioiwake-cho, Seto, Aichi, 489-8642 Japan
TEL
0561-82-5101
taniguchi@tosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Suzuki |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
Address
160 Nishioiwake-cho, Seto, Aichi, 489-8642 Japan
TEL
0561-82-5101
Homepage URL
atsushi-salyu@hotmail.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Allergy, Tosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
Pacific Medico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
公立陶生病院/Tosei General Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 13 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 13 | Day |
Last modified on
| 2017 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025256
