An Investigation of a New Laryngeal Mask Airway LMA Protector

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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Evaluation of LMA Protector

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Detailed Description

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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.

Conditions

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Airway Morbidity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LMA Protector

Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port)

Group Type EXPERIMENTAL

LMA Protector

Intervention Type DEVICE

Insertion of airway device for airway management during gynaecological procedure

Interventions

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LMA Protector

Insertion of airway device for airway management during gynaecological procedure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No