NCT02063516

Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal

Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal - A Perspective, Randomized，Blind Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Detailed description

Condition: The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA Proseal in paralyzed, anesthetized patients. Device: Guardian Laryngeal Mask Device: LMA Proseal Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Conditions

• Efficacy of Oropharyngeal Seal Pressure

Interventions

Type	Name	Description
DEVICE	Guardian Laryngeal Mask	Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.
DEVICE	Proseal Laryngeal Mask Airway	Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2014-02-14
• Last updated: 2015-01-26
• Results posted: 2014-12-18

Locations

1 site across 1 country: China