UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038244 |
|---|---|
| Receipt number | R000043578 |
| Scientific Title | Study of the bevel of tracheal lumen endotracheal opening of double-lumen endobronchial tube |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2022/08/01 11:06:38 |
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Basic information
Public title
Study of the bevel of tracheal lumen endotracheal opening of double-lumen endobronchial tube
Acronym
Study of the bevel of tracheal lumen endotracheal opening of double-lumen endobronchial tube
Scientific Title
Study of the bevel of tracheal lumen endotracheal opening of double-lumen endobronchial tube
Scientific Title:Acronym
Study of the bevel of tracheal lumen endotracheal opening of double-lumen endobronchial tube
Region
| Japan |
Condition
Condition
differential lung ventilation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tracheal lumen opening of double-lumen endobronchial tube gets caught on glottis. There is no study about the relationship between the bevel of tracheal lumen opening and glottis. The aim of this study is to reveal the influence to glottis of the bevel of tracheal lumen opening.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
When volunteers insert the double-lumen endobronchial tube into the artificial airway model, the resistance resulted from the caught of the tracheal lumen opening on glottis is measured by digital force gauge attached to the double-lumen endobronchial tube. 2 different type of the bevel of tracheal lumen openings are compared.
Key secondary outcomes
When volunteers insert the double-lumen encaught of the tracheal lumen opening on glottis is evaluated dobronchial tube into the artificial airway model, the resistance resulted from the by the volunteers inserting the double-lumen endobronchial tube. 2 different type of the bevel of tracheal lumen openings are compared.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Volunteer anesthesiologists insert the double-lumen tube into the artificial airway model.
Interventions/Control_2
Volunteer anesthesiologists insert the double-lumen tube with other condition into the artificial airway model.
Interventions/Control_3
Volunteer anesthesiologists insert the double-lumen tube with other condition into the artificial airway model.
Interventions/Control_4
Volunteer anesthesiologists insert the double-lumen tube with other condition into the artificial airway model.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 24 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Volunteers who are certificated anesthesiologists.
Key exclusion criteria
Volunteers who are not certificated anesthesiologists.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Matsui |
Organization
minaminagano medical center Shinonoi general hospital
Division name
division of anesthesia
Zip code
388-8004
Address
666-1, Shinonoi Ai, Nagano Shi, Nagano Ken, 388-8004, Japan
TEL
026-292-2261
matsuimagawa@gmail.com
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Matsui |
Organization
minaminagano medical center Shinonoi general hospital
Division name
division of anesthesia
Zip code
388-8004
Address
666-1, Shinonoi Ai, Nagano Shi, Nagano Ken, 388-8004, Japan
TEL
026-292-2261
Homepage URL
matsuimagawa@gmail.com
Sponsor or person
Institute
minaminagano medical center Shinonoi general hospital
Institute
Department
Personal name
Funding Source
Organization
minaminagano medical center Shinonoi 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
minaminagano medical center Shinonoi general hospital
Address
666-1, Shinonoi Ai, Nagano Shi, Nagano Ken, 388-8004, Japan
Tel
026-292-2261
sgh.sino.ane@gmail.com
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 | 01 | 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
6
Results
Power analysis suggested 13 volunteers needed for study with airway model, however we detected significant differences when 6 volunteers were recruited. Effect size and power were unknown in this model. That was the reason why sample size was changed.
Results date posted
| 2020 | Year | 04 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Clinical demands for COVID-19 disturb progress in this study.
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 | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043578
