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

Phase 3

Completed

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Guardian Laryngeal Mask; Device: Supreme Laryngeal Mask Airway

• Registration Number: NCT01575236
• Lead Sponsor: Schulthess Klinik

Brief 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-11
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• ASA 1 or 2
• Age 18-75 yr
• Written informed consent

Exclusion Criteria

• Difficult airway
• Non fasted
• BMI > 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guardian	Guardian Laryngeal Mask	Guardian Laryngeal Mask
Supreme	Supreme Laryngeal Mask Airway	Supreme Laryngeal Mask Airway

Primary Outcome Measures

Name	Time	Method
efficacy of oropharyngeal seal pressure	5 min	this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O

Secondary Outcome Measures

Name	Time	Method
anatomic position	5 min	this will be determined fiberoptically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O

Trial Locations

Locations (1)

Universitätsklinik für Anästhesie; 🇦🇹 Innsbruck, Tirol, Austria