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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036378
Receipt No. 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 2019/04/02

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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
Email 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
Email dependonhero@yahoo.co.jp

Sponsor
Institute Seirei Mikatahara General Hospital
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 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
2019 Year 04 Month 02 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041424

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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