UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041332 |
|---|---|
| Receipt number | R000047190 |
| Scientific Title | Diagnostic value of impulse oscillation system in combination with artificial intelligence as alternative method to spirometry. |
| Date of disclosure of the study information | 2020/08/08 |
| Last modified on | 2020/08/06 15:09:19 |
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Basic information
Public title
Diagnostic value of impulse oscillation system in combination with artificial intelligence as alternative method to spirometry.
Acronym
Research of impulse oscillation method with machine learning for prediction of pulmonary function.
Scientific Title
Diagnostic value of impulse oscillation system in combination with artificial intelligence as alternative method to spirometry.
Scientific Title:Acronym
Research of impulse oscillation method with machine learning for prediction of pulmonary function.
Region
| Japan |
Condition
Condition
respiratory obstractive/restrictive disorder.
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ROC analysis for diagnostic value of respiratory obstractive/restrictive disorder.
Basic objectives2
Others
Basic objectives -Others
1. Correlation coefficient between measured value by spirometry and predictive value by oscillometry (Mostgraph).
2. ROC analysis in subgroup of patients with age of less than 70 who has experience of spirometry testing.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ROC analysis of predictive value by oscillometry with machine learning for measured value by spirometry.
Key secondary outcomes
1. Correlation coefficient between measured value by spirometry and predictive value by oscillometry (Mostgraph).
2. ROC analysis in subgroup of patients with age of less than 70 who has experience of spirometry testing.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Recieved both spirometry and Mostgraph in Matsusaka Municipal Hospital before Dec 31 2019.
2. All parameter of both spirometry and Mostgraph was successfully measured.
3. Data of both spirometry and Mostgraph is stored in electronic medical record, and they are available.
Key exclusion criteria
1. With missing data of age or sex.
2. Identified as ineligible case by the investigator.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kentarou |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine, Respiratory Center
Zip code
515-0073
Address
1550, Tonomachi,Matsusaka, Mie, Japan.
TEL
0598-23-1515
kentarou_i_0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine, Respiratory Center
Zip code
515-0073
Address
1550, Tonomachi,Matsusaka, Mie, Japan.
TEL
0598-23-1515
Homepage URL
kentarou_i_0214@yahoo.co.jp
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka Municipal Hospital
Address
1550, Tonomachi,Matsusaka, Mie, Japan.
Tel
0598-23-1515
kentarou_i_0214@ayhoo.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 08 | 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
5539
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Retrospective observational study
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047190
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
