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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005322
Receipt No. R000006324
Scientific Title Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Date of disclosure of the study information 2011/04/01
Last modified on 2013/07/29

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Basic information
Public title Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Acronym Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Scientific Title Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Scientific Title:Acronym Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Region
Japan

Condition
Condition cases of tracheal stenosis
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess the usefulness in tracheal stenosis before and after interventional procedures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of IOS parameters before and after interventional bronchoscopy
Key secondary outcomes Comparison between variable and fixed stenosis in IOS parameters

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 tracheal stenosis
Key exclusion criteria Patients with tracheotomy and a history of pneumonectomy
incapable of performing spirometry and CT
Target sample size 20

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, 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, Japan
TEL 044-977-8111
Homepage URL
Email

Sponsor
Institute Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department

Funding Source
Organization Division of Respiratory and Infectious Diseases, Department of Internal Medicine, St.Marianna University School of 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 (St. Marianna University School of Medicine Hospital)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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
After interventional bronchoscopy, all IOS measurements significantly improved, especially R5 and X20. R5, R5-R20 and X5 changes but not spirometry measurements correlated with changes in MMRC dyspnea scale. 
IOS can potentially be used to differentiate fixed from variable obstruction.
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
2011 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 02 Month 01 Day

Other
Other related information This is an analysis of collected data between April 2008 and December 2010.Twenty consecutive patients with CAO underwent spirometry, IOS, computed tomography, MMRC dyspnea assessment and bronchoscopy before and after interventional bronchoscopy.

Management information
Registered date
2011 Year 03 Month 26 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=R000006324

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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