UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043578