UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052188 |
|---|---|
| Receipt number | R000059563 |
| Scientific Title | Effect of home Nasal High-Flow Oxygen Therapy for patients with interstitial pneumonia |
| Date of disclosure of the study information | 2023/09/14 |
| Last modified on | 2023/09/12 21:04:55 |
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Basic information
Public title
Effect of home Nasal High-Flow Oxygen Therapy for patients with interstitial pneumonia
Acronym
Effect of home Nasal High-Flow Oxygen Therapy for patients with interstitial pneumonia
Scientific Title
Effect of home Nasal High-Flow Oxygen Therapy for patients with interstitial pneumonia
Scientific Title:Acronym
Effect of home Nasal High-Flow Oxygen Therapy for patients with interstitial pneumonia
Region
| Japan |
Condition
Condition
interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to introduce home Nasal High-Flow Oxygen Therapy (NHFT) to interstitial pneumonia patients using home oxygen therapy and to test whether the patients' quality of life (QOL) and Activity of Daily Livings (ADL) are improved by the questionnaire. The purpose of the study is to determine whether NHFT improves patients' quality of life (QOL) and Activity of Daily Livings (ADL) using a questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire (Japanese version of K-Bild) scores before and after introduction of NHFT
Key secondary outcomes
Comparison of SpO2 when using HOT and NHFT.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Home NHFT
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with interstitial pneumonia who are attending respiratory medicine and have been introduced to home oxygen, but whose SpO2 drops to less than 90% on exertion, will be considered.
Patients must be able to attend outpatient clinic with no change in home oxygen level for more than 1 month.
Key exclusion criteria
Patients who are unable to walk
Patients with respiratory disease causing hypoxemia other than interstitial pneumonia
Patients who required hospitalization or a change in the amount of home oxygen within one month
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kurosawa |
Organization
International University of Health and Welfare Narita Hospital
Division name
Respiratory medicine
Zip code
286-8520
Address
852 Hatakeda, Narita City, Chiba 286-8520 Japan
TEL
0476-35-5576
yusuke.kurosawa0813@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kurosawa |
Organization
International University of Health and Welfare Narita Hospital
Division name
Respiratory medicine
Zip code
286-8520
Address
852 Hatakeda, Narita City, Chiba 286-8520 Japan
TEL
0476-35-5576
Homepage URL
yusuke.kurosawa0813@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Chiba District, International University of Health and Welfare, Narita Hospital
Address
852 Hatakeda, Narita City, Chiba 286-8520 Japan
Tel
0476355613
rinri_md@iuhw.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
| 2023 | Year | 09 | Month | 14 | 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
11
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
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059563
