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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032288
Receipt No. R000036590
Scientific Title Randomised Controlled Trials comparing patient tolerance and comfort of Bronchoscopy by nasal insertion and oral insertion
Date of disclosure of the study information 2018/04/18
Last modified on 2018/04/17

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Basic information
Public title Randomised Controlled Trials comparing patient tolerance and comfort of Bronchoscopy by nasal insertion and oral insertion
Acronym Difference of Patient outcome in Bronchoscopy by the insertion route
Scientific Title Randomised Controlled Trials comparing patient tolerance and comfort of Bronchoscopy by nasal insertion and oral insertion
Scientific Title:Acronym Difference of Patient outcome in Bronchoscopy by the insertion route
Region
Japan

Condition
Condition Patients who needs to go under examination by bronchoscopy. Chest and lung diseases.
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the objective is to find out which insertion route, nasal or oral insertion, of bronchoscopy has a better tolerance and comfort.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Discomfort of a insertion route checked by a questionnaire done after bronchoscopy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Bronchoscopy is inserted by nasal route when the bronchoscopy is performed.
Interventions/Control_2 Bronchoscopy is inserted by oral route when the bronchoscopy is performed.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with an indication for bronchoscopy
2)Age 20 years old or more
3)Patient who agreed to attempt in the study after the informed consent was obtained and with sufficient understanding of the study and freedom for rejection
Key exclusion criteria 1)Pregnant women
2)patient who undergo endobronchial ultrasound-guided transbronchial needle aspiration(EBUS-TBNA)
3)Platelet count under 2.0*10^4/mm^2
4)patients who can't discontinue the antiplatelets or anticoagulants
5)Patients with past history of myocardial infarction within 30 days
6)Patients with allergy to lidocaine, midazolam, pethidine
7)Patient with glaucoma
8)Patient with myasthenia gravis
9)Patient under going HIV treatment
10)Patient who is judged as an inappropriate case by the responsible researcher
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Uchida
Organization Asahi general hospital
Division name Respiratory Medicine
Zip code
Address I-1326, Asahi-shi, Chiba-ken, Japan
TEL 0479-63-8111
Email for.u.goodlife@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Uchida
Organization Asahi general hospital
Division name Respiratory Medicine
Zip code
Address I-1326, Asahi-shi, Chiba-ken, Japan
TEL 0479-63-8111
Homepage URL
Email for.u.goodlife@gmail.com

Sponsor
Institute Asahi General Hospital
Institute
Department

Funding Source
Organization Asahi General Hospital
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 18 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 17 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036590

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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