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

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 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

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

Value
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