UMIN-CTR Clinical Trial

Basic information
Public title	The simulation study for accidental tracheal extubation during surgery with prone patients.
Acronym	The simulation study for accidental tracheal extubation during surgery with prone patients.
Scientific Title	The simulation study for accidental tracheal extubation during surgery with prone patients.
Scientific Title:Acronym	The simulation study for accidental tracheal extubation during surgery with prone patients.
Region	Japan

Condition
Condition	Accidental tracheal extubation in the prone position
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate the most reliable device for airway rescue in the prone position.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The time from the start of airway management to the first successful ventilation for the simulation manikin through the inserted device.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Volunteer anesthesiologists in Yokohama City University Hospital
Key exclusion criteria	None
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Miyashita
Organization	Yokohama City University Hospital
Division name	Department of Anesthesiology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	0457872918
Email	yushukyo@yahoo.co.jp

Public contact
Name of contact person	1st name Natsuhiro Middle name Yamamoto Last name Yamamoto
Organization	Yokohama City University Hospital
Division name	Department of Anesthesiology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	0457872918
Homepage URL
Email	natsuyamamo@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
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	Yokohama City University Hospital IRB
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel	045-370-7627
Email	rinri@yokohama-cu.ac.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

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 24 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	2019 Year 12 Month 20 Day
Date of IRB	2019 Year 12 Month 20 Day
Anticipated trial start date	2019 Year 12 Month 20 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is an observational study about airway management for the manikin set prone, performed by anesthesiologists in Yokohama City University Hospital.

Management information
Registered date	2019 Year 12 Month 24 Day
Last modified on	2021 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044441