An Investigation of a New Laryngeal Mask Airway LMA Protector
- Conditions
- Airway Morbidity
- Interventions
- Device: LMA Protector
- Registration Number
- NCT02531256
- Lead Sponsor
- KK Women's and Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- planned elective surgery with indication for LMA use
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LMA Protector LMA Protector Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port)
- Primary Outcome Measures
Name Time Method Number of insertion attempts 5 minutes Time of pickup of device to the presence of carbon dioxide trace on
- Secondary Outcome Measures
Name Time Method Oropharyngeal Leak Pressure 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
Trial Locations
- Locations (1)
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore