NCT01575236

A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Schulthess Klinik · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Detailed description

The GuardianTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, non-crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Conditions

• Adverse Anesthesia Outcome

Interventions

Type	Name	Description
DEVICE	Guardian Laryngeal Mask	ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
DEVICE	Supreme Laryngeal Mask Airway	ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2012-04-11
• Last updated: 2012-08-08

Locations

1 site across 1 country: Austria