UMIN-CTR Clinical Trial

Basic information
Public title	Simulation study of tracheal intubation through an aerosol-box assuming COVID-19
Acronym	Simulation study of tracheal intubation through an aerosol-box assuming COVID-19
Scientific Title	Simulation study of tracheal intubation through an aerosol-box assuming COVID-19
Scientific Title:Acronym	Simulation study of tracheal intubation through an aerosol-box assuming COVID-19
Region	Japan

Condition
Condition	Patients with infectious diseases assuming COVID-19
Classification by specialty	Anesthesiology Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the difficulty of intubation through an aerosol-box used for COVID-19 patients and the appropriate device for intubation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time required to intubate the mannequin
Key secondary outcomes	Difficulty of tracheal intubation and mask ventilation, and Cormack grade

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Volunteer doctorss in Tokyo Women's Medical University Hospital
Key exclusion criteria	doctors who refused to participate
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Idei Middle name Last name Masafumi
Organization	Tokyo Women's Medical University Hospital
Division name	Department of Intensive Care Medicine
Zip code	162-8666
Address	8-1Kawada-cho, Shinjuku, Tokyo, Japan
TEL	0333538111
Email	masafumi203@gmail.com

Public contact
Name of contact person	1st name Masafumi Middle name Last name Idei
Organization	Tokyo Women's Medical University Hospital
Division name	Department of Intensive Care Medicine
Zip code	162-8666
Address	8-1Kawada-cho, Shinjuku, Tokyo, Japan
TEL	0333538111
Homepage URL
Email	masafumi203@gmail.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Self-funding
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	Tokyo Women's Medical University
Address	8-1 Kawada-cho, Shinjuku, Tokyo
Tel	0333538111
Email	krinri.bm@twmu.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	2020 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 10 Month 12 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 05 Month 01 Day
Date of IRB	2020 Year 05 Month 01 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2020 Year 05 Month 08 Day
Date of closure to data entry	2020 Year 05 Month 08 Day
Date trial data considered complete	2020 Year 06 Month 01 Day
Date analysis concluded	2020 Year 06 Month 02 Day

Other

Other related information

This is a simulation study of tracheal intubation and mask ventilation for mannequins with and without an aerosol-box in doctors at Tokyo Women's Medical University Hospital. protocol of procedure We ask the participants to perform the intubation using three different devices with and without aerosol box (SplashGuardCG:SGCG), which gives six attempts in each. The orders of procedure are randomized using lottery metod. Intubation devices Macintosh Laryngoscope (ML) (Riester, Jungignen, Germany) with size 3 blade AirWay ScopeTM S-100 (AWS) (Pentax, Tokyo, Japan) McGRATH MACTM (MAC) (Aircraft Medical Ltd., Edinburgh, UK) with size 3 blade Tracheal tube 7.0 mm cuffed tracheal tube (SealGuard EvacTM, Covidien, Dublin, Ireland) stylet (ShileyTM Intubation Stylet, Covidien, Dublin, Ireland) (when intubating with ML and MAC) Simulation manikin Laerdal Airway Management Trainer (Laerdal Medical Japan Ltd., Tokyo, Japan) on the bed in our intensive care unit (ICU) The height of the bed and the pillow, and the position of the manikin are freely adjusted by the participants. Support of procedure The same certified anesthesiologist supports as requested by the subjects, such as inflating a cuff, removing a stylet, or performing the backward upward and rightward pressure (BURP) maneuver through the right holes of aerosol box (SGCG). Intubation time We define the intubation time as the time taken from the participants held the intubation device until the ventilation with bag valve mask via the successfully placed endotracheal tube was confirmed.

Management information
Registered date	2020 Year 05 Month 01 Day
Last modified on	2020 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045947