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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027820
Receipt No. R000031875
Scientific Title Comparison of airway management by using LMA Protector with that of LMA Supreme in the clinical situation
Date of disclosure of the study information 2017/06/20
Last modified on 2022/08/05

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Basic information
Public title Comparison of airway management by using LMA Protector with that of LMA Supreme in the clinical situation
Acronym Comparison of airway management by using LMA Protector with that of LMA Supreme in the clinical situation
Scientific Title Comparison of airway management by using LMA Protector with that of LMA Supreme in the clinical situation
Scientific Title:Acronym Comparison of airway management by using LMA Protector with that of LMA Supreme in the clinical situation
Region
Japan

Condition
Condition Patients who will be planned to the operation
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will compare of usefulness of the airway management by using new device LMA Protector with that of LMA Supreme
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes with or without of postoperative throat, Numerical Rating Score (NRS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The Group which using LMA Protector
Interventions/Control_2 The Group which using LMA Supreme
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
80 years-old >
Gender Male and Female
Key inclusion criteria The patients who will be planned to the operations
Key exclusion criteria The patients with trauma, ileum, abdominal cavity inflammation, peristalsis dysfunction, gatroesophageal reflux, severe obesity (> BMI 35), difficult mutual understanding, failed to agree with this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Mitsutaka
Middle name
Last name Edanaga
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code 0608543
Address S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email edanaka@sapmed.ac.jp

Public contact
Name of contact person
1st name Kouji
Middle name
Last name Hamaya
Organization Sapporo Medical University School of Medicine
Division name Hospital section
Zip code 060-8543
Address S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email ko-hamaya-923@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Sapporo Medical University School of Medicine
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 Hospital sections, Sapporo Medical University School of Medicine
Address S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel 011-611-2111
Email ko-hamaya-923@sapmed.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
2017 Year 06 Month 20 Day

Related information
URL releasing protocol https://web.sapmed.ac.jp/masui/patients/research/pdf/292-013.pdf
Publication of results Unpublished

Result
URL related to results and publications https://web.sapmed.ac.jp/masui/patients/research/pdf/292-013.pdf
Number of participants that the trial has enrolled 60
Results The NRS score of LMA Protector was statistically significantly lower than that of LMA Supreme.
Results date posted
2022 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics There were no significant differences in patients characteristics between the two groups.
Participant flow A total of 64 patients were enrolled and randomized into LMA Protector or LMA Supreme groups. Four patients were excluded due to changes in the surgical technique and position. Hence, a total of 60 patients were enrolled and randomized into LMA Protector and LMA Supreme groups. After excluding two patients in each group due to insertion difficulties, 28 participants each were allocated to the LMA Protector and LMA Supreme groups, all of whom were successfully followed-up and their outcomes analyzed.
Adverse events No adverse events occurred.
Outcome measures OPLP of LMA Protector was significantly higher than that of LMA Supreme (P = .0047).LMA Protector provided a better view of the tip position compared with LMA Supreme (P = .0041). Time to insertion was longer with LMA Protector than LMA Supreme (P = .0006). There were no significant differences in the number of attempts until successful insertion (P = 0.223) and initial cuff pressure (P = 0.495).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 05 Month 11 Day
Date of IRB
2017 Year 05 Month 11 Day
Anticipated trial start date
2017 Year 06 Month 21 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

Management information
Registered date
2017 Year 06 Month 19 Day
Last modified on
2022 Year 08 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031875

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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