UMIN-CTR Clinical Trial

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