An Investigation of a New Laryngeal Mask Airway LMA Protector
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of insertion attempts
Study Overview
Brief Summary
Evaluation of LMA Protector
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LMA Protector
Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port)
Intervention: LMA Protector (Device)
Outcomes
Primary Outcomes
Number of insertion attempts
Time Frame: 5 minutes
Time of pickup of device to the presence of carbon dioxide trace on
Secondary Outcomes
- Oropharyngeal Leak Pressure(5 minutes)
Investigators
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital