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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002403
Receipt No. R000002291
Scientific Title Evaluation of Central Airway Stenosis using impulse oscillation system
Date of disclosure of the study information 2009/08/30
Last modified on 2013/07/29

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Basic information
Public title Evaluation of Central Airway Stenosis using impulse oscillation system
Acronym Evaluation of Central Airway Stenosis using impulse oscillation system
Scientific Title Evaluation of Central Airway Stenosis using impulse oscillation system
Scientific Title:Acronym Evaluation of Central Airway Stenosis using impulse oscillation system
Region
Japan

Condition
Condition Cases of central airway stenosis
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate if the impulse oscillation system measurements were related to spirometry for central airway stenosis cases and if feasable for during pre- and post-operative examination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between Impulse oscillation system and spirometry
Key secondary outcomes Evaluation of airway collapsibility and compliance

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 Patients with central airway stenosis
Key exclusion criteria Low volume or poor breathing at rest, incapable of spirometry, tracheostomy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamichi Mineshita
Organization St. Marianna university school of medicine
Division name Division of Respiratory and Infectious diseases, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao Miyamae-ku,Kawasaki,Kanagawa,Japan
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Handa
Organization St. Marianna University School of Medicine
Division name Division of Respiratory and Infectious Diseases, Department of Internal medicine
Zip code
Address 2-16-1 Sugao Miyamae-ku,Kawasaki,Kanagawa,Japan
TEL 044-977-8111
Homepage URL
Email hiroshihstv@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of internal medicine
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of internal medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 聖マリアンナ医科大学病院(神奈川)

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In patients with tracheal stenosis, there were not significant correlation between IOS and spirometry. Patients with bronchial stenosis showed significant correlation between IOS and spirometry.
In 13 patients with malignant airway stenosis, the cross-sectional area at the narrowest segment revealed significant correlation with PEF, R5, R20 and X20. 
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
2009 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 06 Month 01 Day
Date trial data considered complete
2010 Year 06 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information Retrospective study

Management information
Registered date
2009 Year 08 Month 30 Day
Last modified on
2013 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002291

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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