NCT00626951

Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients

Detailed description

The LMA Supreme is a new extraglottic airway device which brings together features of both the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use - prevention of disease transmission). The new features are that the airway tube incorporates a drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been strengthened to prevent airway obstruction from infolding and epiglottic fins have been added to prevent airway obstruction from epiglottic downfolding. In the following randomized, crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed, anesthetized patients

Conditions

• Paralysis

Interventions

Type	Name	Description
DEVICE	LMA Supreme	Extraglottic airway devices
DEVICE	LMA ProSeal

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-02-29
• Last updated: 2008-07-03

Locations

1 site across 1 country: Austria