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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038244
Receipt No. 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 2019/11/13

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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
Email 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
Email matsuimagawa@gmail.com

Sponsor
Institute minaminagano medical center Shinonoi general hospital
Institute
Department

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
Email 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
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 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
2019 Year 12 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
2019 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043578

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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