UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048853 |
|---|---|
| Receipt number | R000055638 |
| Scientific Title | A study of the effectiveness of local anesthesia using aerosol sprays and saliva ejectors for bronchoscopy. |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2024/12/09 18:15:42 |
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Basic information
Public title
A study of the effectiveness of local anesthesia using aerosol sprays and saliva ejectors for bronchoscopy.
Acronym
A study of the effectiveness of local anesthesia using aerosol sprays and saliva ejectors for bronchoscopy.
Scientific Title
A study of the effectiveness of local anesthesia using aerosol sprays and saliva ejectors for bronchoscopy.
Scientific Title:Acronym
A study of the effectiveness of local anesthesia using aerosol sprays and saliva ejectors for bronchoscopy.
Region
| Japan |
Condition
Condition
Lung cancer, Diffuse pulmonary disease, Pulmonary infection
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of local anesthesia by continuous oral suction and spraying using a saliva ejector in bronchoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discomfort assessment using visual analogue scale (VAS) cough frequency in bronchoscopy
Key secondary outcomes
Changes in vital signs (blood pressure, pulse rate, SpO2), complications, and duration of examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Bronchoscopy in the usual way.
Interventions/Control_2
Local anesthesia with Xylocaine using aerosol spray.
Interventions/Control_3
Continuous oral suction with a salivary ejector.
Interventions/Control_4
Local anesthesia using aerosol spray and continuous oral suction with a salivary ejector.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing bronchoscopy.
Patients who are 18 years of age or older at the time consent is obtained.
Patients who have been informed of the details of this clinical research and have given written consent to participate in this study.
Key exclusion criteria
Patients who have been considered by their attending physician as being inappropriate to participate in this clinical study.
Patients undergoing tracheostomy or tracheal intubation.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Tsuchiya |
Organization
Shizuoka Saiseikai General hospital
Division name
Respiratory medicine
Zip code
422-8527
Address
1-1-1 Oshika, Suruga-ku, Shizuoka City, Shizuoka Prefecture
TEL
054-285-6171
bandfor2004@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Tsuchiya |
Organization
Shizuoka Saiseikai General hospital
Division name
Respiratory medicine
Zip code
422-8527
Address
1-1-1 Oshika, Suruga-ku, Shizuoka City, Shizuoka Prefecture
TEL
054-285-6171
Homepage URL
bandfor2004@yahoo.co.jp
Sponsor or person
Institute
Shizuoka Saiseikai General hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Saiseikai General hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Saiseikai General Hospital Ethics and Compliance Committee
Address
1-1-1 Oshika, Suruga-ku, Shizuoka City, Shizuoka Prefecture
Tel
054-285-6171
k179825@siz.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
静岡済生会総合病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2212534524001898
Number of participants that the trial has enrolled
120
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
Main results already published
Date of protocol fixation
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055638
