An Investigation of a New Laryngeal Mask Airway LMA Protector (LMA)

February 28, 2016 updated by: KK Women's and Children's Hospital
Evaluation of LMA Protector

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital

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

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • planned elective surgery with indication for LMA use

Exclusion Criteria:

  • body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LMA Protector
Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port)
Device: LMA Protector
Insertion of airway device for airway management during gynaecological procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of insertion attempts
Time Frame: 5 minutes
Time of pickup of device to the presence of carbon dioxide trace on
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal Leak Pressure
Time Frame: 5 minutes
Closure of expiratory valve of circle anaesthetic breathing system and noting the airway pressure in the breathing system at equilibration with cuff pressure of 60cmH2O or up to maximum of 40cmH2O
5 minutes

Collaborators and Investigators

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

Sponsor

KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 28, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013/709/D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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