The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paralysis
- Sponsor
- Medical University Innsbruck
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Oropharyngeal leak pressure
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Oropharyngeal leak pressure
Time Frame: 5 min
Secondary Outcomes
- Ease of insertion(1 min)