UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032288 |
|---|---|
| Receipt number | 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 | 2024/12/24 07:52:48 |
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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 | Yoshitaka |
| Middle name | |
| Last name | Uchida |
Organization
Asahi general hospital
Division name
Respiratory Medicine
Zip code
2892511
Address
I-1326, Asahi-shi, Chiba-ken, Japan
TEL
0479-63-8111
for.u.goodlife@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Uchida |
Organization
Asahi general hospital
Division name
Respiratory Medicine
Zip code
2892511
Address
I-1326, Asahi-shi, Chiba-ken, Japan
TEL
0479-63-8111
Homepage URL
for.u.goodlife@gmail.com
Sponsor or person
Institute
Asahi General Hospital
Institute
Department
Personal name
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
Asahi General Hospital
Address
I-1326, Asahi-shi, Chiba-ken, Japan
Tel
0479-63-8111
tinoue@hospital.asahi.chiba.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
| 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
| 2022 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
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
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036590
