An Investigation of a New Laryngeal Mask Airway LMA Protector

KK Women's and Children's Hospital

Status: Completed

Conditions: Airway Morbidity

Treatments: Device: LMA Protector

Study type: Interventional

Funder types: Other

Identifiers

NCT02531256

2013/709/D

Details and patient eligibility

About

Evaluation of LMA Protector

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

LMA Protector

Experimental group

Description:

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

Treatment:

Device: LMA Protector