UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038968 |
|---|---|
| Receipt number | R000044441 |
| Scientific Title | The simulation study for accidental tracheal extubation during surgery with prone patients. |
| Date of disclosure of the study information | 2019/12/24 |
| Last modified on | 2021/06/28 11:08:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
natsuyamamo@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044441
