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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020488
Receipt No. R000023661
Scientific Title Characteristics of bronchoscopy in the elderly
Date of disclosure of the study information 2016/01/07
Last modified on 2016/01/07

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Basic information
Public title Characteristics of bronchoscopy in the elderly
Acronym Bronchoscopy in the elderly
Scientific Title Characteristics of bronchoscopy in the elderly
Scientific Title:Acronym Bronchoscopy in the elderly
Region
Japan

Condition
Condition All respiratory diseases requiring bronchoscopy
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the characteristics of bronchoscopy in the elderly
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of parameters (e.g., patient background, adverse events etc) among age groups (25-64y/o, 65-79y/o, more than and equal to 80y/o).
Key secondary outcomes Analysis of correlation between severity of underlying conditions (estimated by Charlson comorbidity index) and adverse events.

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
25 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All cases for whom bronchoscopy is performed
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Oyamada
Organization National Hospital Organization Tokyo Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1 Higashigaoka Meguro-ku Tokyo Japan
TEL 03-3411-0111
Email yoyamada@ntmc.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Oyamada
Organization National Hospital Organization Tokyo Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1 Higashigaoka Meguro-ku Tokyo Japan
TEL 03-3411-0111
Homepage URL http://www.ntmc.go.jp/p_guide/contents/146.html
Email yoyamada@ntmc.hosp.go.jp

Sponsor
Institute Department of Respiratory Medicine
National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization Department of Respiratory Medicine
National Hospital Organization Tokyo Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 国立病院機構東京医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 07 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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design of the study: Cohort study
Materials: All cases in whom bronchoscopy is conducted(Jan 2016 through Mar 2018).
Parameters:
1) Patients' background (age, gender, underlying conditions, medications etc)
2) Details in bronchosopic maneuvers (premedication, oxygen demand, types of maneuvers etc)
3) Adverse events
4) Diagnosis



Management information
Registered date
2016 Year 01 Month 07 Day
Last modified on
2016 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023661

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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