LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients

NCT ID: NCT03984032

Last Updated: 2019-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2019-02-19

Brief Summary

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Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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LMA Protector Cuff Pilot

Group Type EXPERIMENTAL

LMA Supreme

Intervention Type DEVICE

Assessing the clinical performance of LMA Supreme

LMA Supreme

Group Type ACTIVE_COMPARATOR

LMA Protector Cuff Pilot

Intervention Type DEVICE

Assessing the clinical performance of LMA Protector Cuff Pilot

Interventions

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LMA Protector Cuff Pilot

Assessing the clinical performance of LMA Protector Cuff Pilot

Intervention Type DEVICE

LMA Supreme

Assessing the clinical performance of LMA Supreme

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.

Exclusion Criteria

* BMI \> 35
* Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more)
* Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liu Chian Yong

OTHER

Sponsor Role lead

Responsible Party

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Liu Chian Yong

Consultant Anaesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UKM PPI/111/8/JEP-2018-007

Identifier Type: -

Identifier Source: org_study_id

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