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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020489
Receipt No. 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

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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
Email 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
Email nakanishi.anest@gmail.com

Sponsor
Institute JCHO Tokuyama Central Hospital, Anesthesiology
Institute
Department

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
Email

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
URL(English) https://upload.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


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