UMIN-CTR Clinical Trial

Basic information
Public title	PCV technique; mannequin simulation study
Acronym	PCV technique; mannequin simulation study
Scientific Title	PCV technique; mannequin simulation study
Scientific Title:Acronym	PCV technique; mannequin simulation study
Region	Japan

Condition
Condition	Tracheostomy
Classification by specialty	Oto-rhino-laryngology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A tracheotomy may be performed if severe respiratory complications occur or if airway management becomes difficult. In recent years, even in patients who have become severely ill due to the new coronavirus, tracheostomy is often performed for treatment. It has been considered desirable to perform tracheostomy under local anesthesia and maintain the patient's own breathing. However, aerosol infections caused by the new coronavirus have been reported, and the trend is that tracheostomy under general anesthesia is safe as an infection control measure. When performing a tracheostomy under general anesthesia, it is important not to break the cuff of the tube in terms of infection control and safety. Currently, there are palpation method and Pressure control ventilation method (hereinafter referred to as PCV method) as techniques for protecting the cuff of the tube. It has not been considered which of these methods is safer and more reliable for everyone.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cuff position accuracy
Key secondary outcomes	Cuff pressure, time to tracheal tube placement, subject confidence (VAS scale).

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Palpation
Interventions/Control_2	PCV technique.
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	23 years-old <=
Age-upper limit	35 years-old >
Gender	Male and Female
Key inclusion criteria	An initial trainee who has completed anesthesia training at our hospital.
Key exclusion criteria	Those for which consent was not obtained.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Kojima
Organization	Asahi General Hospital
Division name	Anestheisology
Zip code	289-2511
Address	Asahi city, I 1326
TEL	0479632211
Email	cojicoji1109@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Kojima
Organization	Asahi General Hospital
Division name	Anestheisology
Zip code	289-2511
Address	Asahi city, I 1326
TEL	0479632211
Homepage URL
Email	cojicoji1109@gmail.com

Sponsor
Institute	Asahi General Hospital
Institute
Department

Funding Source
Organization	Asahi General Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asahi General Hospital
Address	Asahi city, I 1326
Tel	0479632211
Email	cojicoji1109@gmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	122222
Org. issuing International ID_1	Asahi General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 03 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
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	2022 Year 02 Month 28 Day
Date of IRB	2021 Year 12 Month 24 Day
Anticipated trial start date	2022 Year 03 Month 01 Day
Last follow-up date	2024 Year 03 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 02 Month 28 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053645