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Clinical Trials/NCT00626951
NCT00626951
Completed
Not Applicable

The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients

Medical University Innsbruck1 site in 1 country94 target enrollmentDecember 2007
ConditionsParalysis

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

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
March 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Medical University Innsbruck

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)

Study Sites (1)

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