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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038571
Receipt No. R000043958
Scientific Title Disinhibition during bronchoscopy with sedation
Date of disclosure of the study information 2019/11/13
Last modified on 2020/05/14

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Basic information
Public title Disinhibition during bronchoscopy with sedation
Acronym Disinhibition during bronchoscopy with sedation
Scientific Title Disinhibition during bronchoscopy with sedation
Scientific Title:Acronym Disinhibition during bronchoscopy with sedation
Region
Japan

Condition
Condition Condition needed bronchoscopy
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of disinhibition during bronchoscopy and factors associated with disinhibiton
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Factors associated with disinhibiton
Key secondary outcomes Prevalence of disinhibition
Association of satisfaction of bronchoscopy
Association of complication

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 who are performed bronchoscopy
Key exclusion criteria Patients who have difficulty with completing questionnaire
Patients who are considered as unfit by researchers
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Matsumoto
Organization Saiseikai-Noe Hospital
Division name Department of Respiratory Medicine
Zip code 536-0001
Address 1-3-25, Furuichi, Jyoto-ku, Osaka
TEL 0669320401
Email mtakeshi@noe.saiseikai.or.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Matsumoto
Organization Saiseikai-Noe Hospital
Division name Department of Respiratory Medicine
Zip code 536-0001
Address 1-3-25, Furuichi, Jyoto-ku, Osaka
TEL 0669320401
Homepage URL
Email mtakeshi@noe.saiseikai.or.jp

Sponsor
Institute Saiseikai-Noe Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saiseikai-Noe Hospital
Address 1-3-25, Furuichi, Jyoto-ku, Osaka
Tel 0669320401
Email yu.tsuruda@noe.saiseikai.or.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
2019 Year 11 Month 13 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 Open public recruiting
Date of protocol fixation
2019 Year 11 Month 13 Day
Date of IRB
2019 Year 11 Month 13 Day
Anticipated trial start date
2019 Year 11 Month 13 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study ; descriptive epidemiology

Management information
Registered date
2019 Year 11 Month 13 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043958

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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