UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020489 |
|---|---|
| Receipt number | R000023660 |
| Scientific Title | Learning curve for LMA ProsealTM insertion: a prospective observational study |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2020/06/11 09:43:49 |
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Basic information
Public title
Learning curve for LMA ProsealTM insertion: a prospective observational study
Acronym
Learning curve for LMA ProsealTM insertion
Scientific Title
Learning curve for LMA ProsealTM insertion: a prospective observational study
Scientific Title:Acronym
Learning curve for LMA ProsealTM insertion
Region
| Japan |
Condition
Condition
Patients undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the learning curve for LMA ProsealTM insertion
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The learning curve for the successful LMA ProsealTM insertion
Key secondary outcomes
Time for LMA ProsealTM insertion
The rate of blood adherence to LMA ProsealTM
The success rate of bag-and mask ventilation
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
Junior residents
Key exclusion criteria
Junior residents who have an experience of insertion LMA ProsealTM
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
nakanishi.anest@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
Homepage URL
nakanishi.anest@gmail.com
Sponsor or person
Institute
JCHO Tokuyama Central Hospital, Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
JCHO Tokuyama Central Hospital
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
Address
Tel
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
| 2016 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32447454/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32447454/
Number of participants that the trial has enrolled
15
Results
Each resident encountered 44+/-5 (mean+/-SD) cases of pLMA insertion, and 14/15 achieved proficiency in performing pLMA insertion after 20+/-8 cases. Success rate (76%, 86%, 91%, and 93%; P < 0.001) and insertion time (45 s, 35 s, 31 s, and 26 s; P < 0.001) significantly improved with increased experience; however, incidences of bleeding (16%, 10%, 8%, and 10%; P = 0.124) and reflex (5%, 3%, 3%, and 3%; P = 0.54) remained unchanged.
Results date posted
| 2020 | Year | 06 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Novice residents in a tertiary teaching hospital.
Participant flow
All 15 novice residents participated in the study.
Adverse events
None.
Outcome measures
Successful insertion of LMA ProSeal, insertion time, and incidence of bleeding and reflex.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 24 | Day |
Other
Other related information
Study design: Prospective non-interventional observational study
Recruitment: Junior residents under training our hospital
(From January 2016 to March 2017)
Management information
Registered date
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2020 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023660
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
