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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041332
Receipt No. 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

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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
Email 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
Email kentarou_i_0214@yahoo.co.jp

Sponsor
Institute Matsusaka Municipal Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047190

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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