UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038571
Receipt number R000043958
Scientific Title Disinhibition during bronchoscopy with sedation
Date of disclosure of the study information 2019/11/13
Last modified on 2023/05/17 12:15:24

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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 or person

Institute

Saiseikai-Noe Hospital

Institute

Department

Personal name



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

Completed

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

2023 Year 05 Month 17 Day



Link to view the page

Value
https://center6.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