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

June 9, 2019 updated by: Liu Chian Yong

Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
        • Universiti Kebangsaan Malaysia Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LMA Supreme
Device: LMA Protector Cuff Pilot
Assessing the clinical performance of LMA Protector Cuff Pilot
Experimental: LMA Protector Cuff Pilot
Device: LMA Supreme
Assessing the clinical performance of LMA Supreme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal leak pressure (OLP)
Time Frame: During induction of anaesthesia
To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme
During induction of anaesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean time to insertion
Time Frame: During induction of anaesthesia
To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme
During induction of anaesthesia
Gastric tube insertion
Time Frame: After induction of anaesthesia
To compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme
After induction of anaesthesia
Laryngeal view
Time Frame: After induction of anaesthesia
To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme
After induction of anaesthesia
Complications
Time Frame: 24 hours
To compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liu Chian Yong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2018

Primary Completion (Actual)

February 19, 2019

Study Completion (Actual)

February 19, 2019

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

June 9, 2019

First Posted (Actual)

June 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 9, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UKM PPI/111/8/JEP-2018-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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