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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
History of Changes
  Purpose

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 Intervention
Paralysis
 Device: LMA Supreme
Device: LMA ProSeal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients

Resource links provided by NLM:

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Oropharyngeal leak pressure [ Time Frame: 5 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of insertion [ Time Frame: 1 min ] [ Designated as safety issue: No ]
Enrollment: 94
Study Start Date: December 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
LMA Supreme
 Device: LMA Supreme
Extraglottic airway devices
Experimental: 2
LMA ProSeal
 Device: LMA ProSeal

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

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Christian Keller MD MSc, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT00626951     History of Changes
Other Study ID Numbers: 07208763-1
Study First Received: February 15, 2008
Last Updated: June 25, 2008
Health Authority: Austria: Federal Ministry for Health and Women

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

ClinicalTrials.gov processed this record on March 02, 2015