UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044235 |
|---|---|
| Receipt number | R000028449 |
| Scientific Title | Invention of a novel simulation for needle cricothyroidotomy to improve education system |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2021/05/17 21:17:31 |
* 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
Invention of a novel simulation for needle cricothyroidotomy to improve education system
Acronym
Invention of a novel simulation for needle cricothyroidotomy to improve education system
Scientific Title
Invention of a novel simulation for needle cricothyroidotomy to improve education system
Scientific Title:Acronym
Invention of a novel simulation for needle cricothyroidotomy to improve education system
Region
| Japan |
Condition
Condition
difficult airway management
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are making a new simulator for cricothyroidotomy, and prove its validity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
success rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Using the available commercial simulator
Interventions/Control_2
Using the new original simulator
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
Junior resident
Key exclusion criteria
with experience of cricothyroidtomy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Katayama |
Organization
Kyorin University
Division name
the faculty of Anesthesiology
Zip code
181-0061
Address
Shinkawa Mitaka-city Tokyo
TEL
0422475511
atsuko-pm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Katayama |
Organization
kyorin University
Division name
the faculty of Anesthesiology
Zip code
181-0061
Address
Shinkawa Mitaka-city Tokyo
TEL
0422475511
Homepage URL
atsuko-pm@umin.ac.jp
Sponsor or person
Institute
Kyorin University the faculty of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
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
Kyorin University the faculty of Anesthesiology
Address
shinkawa Mitaka-city Tokyo JAPAN
Tel
0422475511
atsuko-pm@umin.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
| 2021 | Year | 05 | Month | 17 | 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
47
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
| 2016 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028449
