UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056316 |
|---|---|
| Receipt number | R000064338 |
| Scientific Title | A randomized control study of the efficacy of asymmetrical high flow nasal cannula interface in patients with acute exacerbation of interstitial pneumonia. |
| Date of disclosure of the study information | 2024/12/19 |
| Last modified on | 2024/12/26 16:55:54 |
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Basic information
Public title
A randomized control study of the efficacy of asymmetrical high flow nasal cannula interface in patients with acute exacerbation of interstitial pneumonia.
Acronym
A randomized control study of the efficacy of asymmetrical high flow nasal cannula interface in patients with acute exacerbation of interstitial pneumonia.
Scientific Title
A randomized control study of the efficacy of asymmetrical high flow nasal cannula interface in patients with acute exacerbation of interstitial pneumonia.
Scientific Title:Acronym
A randomized control study of the efficacy of asymmetrical high flow nasal cannula interface in patients with acute exacerbation of interstitial pneumonia.
Region
| Japan |
Condition
Condition
interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of asymmetric high flow nasal cannula interface in patients with acute exacerbation of interstitial pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The minimum SpO2 during rehabilitation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants wear symmetrical high flow nasal cannula interface at least six hours, then switch to asymmetrical high flow nasal cannula interface.
Interventions/Control_2
Participants wear asymmetrical high flow nasal cannula interface at least six hours, then switch to symmetrical high flow nasal cannula interface.
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 hospitalized Kurashiki central hospital because of acute exacerbation of interstitial pneumonia and received high-flow nasal therapy, who underwent methylprednisolone pulse therapy within 10 days and began rehabilitation.
Key exclusion criteria
Difference of 10% or more in required FiO2 of high flow therapy at rest between the day of the registration and the day before the registration.
Intolerance to high flow therapy.
Cognitive disorder.
Pregnancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Amano |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-0052
Address
1-1-1, Miwa, Kurashiki city, Okayama, Japan
TEL
0864220210
aa16513@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Amano |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-0052
Address
1-1-1, Miwa, Kurashiki city, Okayama, Japan
TEL
0864220210
Homepage URL
aa16513@kchnet.or.jp
Sponsor or person
Institute
Akihiko Amano, Department of Respiratory Medicine, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki city, Okayama, Japan
Institute
Department
Personal name
Akihiko Amano
Funding Source
Organization
None
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
Ethics Committee Kurashiki Central Hospital
Address
1-1-1, Miwa, Kurashiki city, Okayama, Japan
Tel
0864220210
www-adm@kchnet.or.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
| 2024 | Year | 12 | Month | 19 | 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
| 2024 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 01 | 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
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064338
