Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

Not Applicable

Completed

• Conditions: Paralysis
• Interventions: Device: LMA Supreme; Device: LMA ProSeal

• Registration Number: NCT00626951
• Lead Sponsor: Medical University Innsbruck

Brief 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

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-29
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-25
• Last Update Posted: 2008-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• American Society of Anesthesiology physical status grade I-II
• Age 18-80 yr
• Elective gynecological surgery
• Supine position

Exclusion Criteria

• Known or predicted difficult airway
• Body mass index >35 kg m-2
• Risk of aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	LMA Supreme	LMA Supreme
2	LMA ProSeal	LMA ProSeal

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	5 min

Secondary Outcome Measures

Name	Time	Method
Ease of insertion	1 min

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria