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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000040289
Receipt No. R000045947
Scientific Title Simulation study of tracheal intubation through an aerosol-box assuming COVID-19
Date of disclosure of the study information 2020/05/01
Last modified on 2020/11/15

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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/ctr_e/ctr_view.cgi?recptno=R000045947

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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