A Randomized Crossover Study of the LMA SupremeTM Versus Ambu-Aura GainTM in Adult Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Schulthess Klinik
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- oropharyngeal seal pressure
Study Overview
Brief Summary
The Ambu-Aura GainTM 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, 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 Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA 1 or 2
- •Age 19-65 yr
- •Written informed consent
Exclusion Criteria
- •Difficult airway
- •Non fasted
- •BMI > 35
Arms & Interventions
LMA SupremeTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
Intervention: function tests (Procedure)
LMA SupremeTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
Intervention: LMA SupremeTM (Device)
Ambu-Aura GainTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
Intervention: function tests (Procedure)
Ambu-Aura GainTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
Intervention: Ambu-Aura GainTM (Device)
Outcomes
Primary Outcomes
oropharyngeal seal pressure
Time Frame: 5 minutes
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
Secondary Outcomes
- anatomic position(5 minutes)