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Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway (Supreme)

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ClinicalTrials.gov Identifier: NCT00626951
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : July 3, 2008
Sponsor:
Information provided by:
Medical University Innsbruck

Study Description
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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

Condition or disease Intervention/treatment Phase
Paralysis Device: LMA Supreme Device: LMA ProSeal Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients
Study Start Date : December 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
LMA Supreme
 Device: LMA Supreme
Extraglottic airway devices
Experimental: 2
LMA ProSeal
 Device: LMA ProSeal


Outcome Measures
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Primary Outcome Measures :
  1. Oropharyngeal leak pressure [ Time Frame: 5 min ]

Secondary Outcome Measures :
  1. Ease of insertion [ Time Frame: 1 min ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626951


Locations
Austria
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Christian Keller, MD, MSc Medical University Innsbruck
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Christian Keller MD MSc, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT00626951     History of Changes
Other Study ID Numbers: 07208763-1
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: July 3, 2008
Last Verified: June 2008

Keywords provided by Medical University Innsbruck:
LMA Supreme
LMA ProSeal
Laryngeal mask airway
Ventilation

Additional relevant MeSH terms:
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants