UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020488 |
|---|---|
| Receipt number | 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 19:55:15 |
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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
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
yoyamada@ntmc.hosp.go.jp
Sponsor or person
Institute
Department of Respiratory Medicine
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023661
