UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027820 |
|---|---|
| Receipt number | 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 08:53:23 |
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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
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
ko-hamaya-923@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031875
