A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
- Conditions
- Adverse Anesthesia Outcome
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- ASA 1 or 2
- Age 18-75 yr
- Written informed consent
- Difficult airway
- Non fasted
- BMI > 35
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Universitätsklinik für Anästhesie🇦🇹Innsbruck, Tirol, Austria