UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040289 |
|---|---|
| Receipt number | 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 19:28:34 |
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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
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
masafumi203@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045947
