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Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

This study has been completed.
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00626951
First received: February 15, 2008
Last updated: June 25, 2008
Last verified: June 2008

February 15, 2008
June 25, 2008
December 2007
March 2008   (final data collection date for primary outcome measure)
Oropharyngeal leak pressure [ Time Frame: 5 min ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626951 on ClinicalTrials.gov Archive Site
Ease of insertion [ Time Frame: 1 min ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway
The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Paralysis
  • Device: LMA Supreme
    Extraglottic airway devices
  • Device: LMA ProSeal
  • Experimental: 1
    LMA Supreme
    Intervention: Device: LMA Supreme
  • Experimental: 2
    LMA ProSeal
    Intervention: Device: LMA ProSeal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00626951
07208763-1
No
Christian Keller MD MSc, Medical University Innsbruck
Medical University Innsbruck
Not Provided
Principal Investigator: Christian Keller, MD, MSc Medical University Innsbruck
Medical University Innsbruck
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP