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Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

This study is currently recruiting participants.
Verified May 2012 by Penn State University
Sponsor:
Information provided by (Responsible Party):
Sonia Vaida, Penn State University
ClinicalTrials.gov Identifier:
NCT00836095
First received: February 2, 2009
Last updated: January 31, 2013
Last verified: May 2012
History of Changes
  Purpose

Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.

The research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.


Condition Intervention Phase
Adverse Effect of Unspecified General Anesthetics
 Device: Supreme Laryngeal mask airway
Device: Proseal laryngeal mask airway
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Primary variable outcomes are: insertion time and insertion success rate [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxygenation, ventilation ,malposition frequency, fiberoptic view (of the final anatomic position), oropharyngeal leak pressure, ventilatory parameters, ease of gastric tube insertion and need for interventions to achieve an effective airway. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Supreme LMA

Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.

The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.

 Device: Supreme Laryngeal mask airway
Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
Device: Proseal laryngeal mask airway
Proseal is a multiple use, variant of the laryngeal mask airway
Active Comparator: Proseal LMA

Proseal is a multiple use, variant of the laryngeal mask airway.

The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.

 Device: Supreme Laryngeal mask airway
Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
Device: Proseal laryngeal mask airway
Proseal is a multiple use, variant of the laryngeal mask airway

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 75 years
  • ASA I and II
  • Mallampatti class: I and II
  • Thyromental distance > than 6.5 cm
  • Interincisor distance > than 3 cm
  • BMI < 35 Kg/m2
  • Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal surgical procedures in supine position

Exclusion Criteria:

  • Weight < 50 kg
  • BMI > 35 Kg/m2
  • Pregnant patients
  • Known or expected difficult airway
  • Patients with active, untreated and unresolved gastroesophageal reflux
  • Esophageal pathology, pulmonary pathology
  • Laparoscopic procedures
  • ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836095

Contacts
Contact: Sonia J Vaida, M.D. 717-531-0000 ext 8434 svaida@psu.edu

Locations
United States, Pennsylvania
PennState Hershey Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Sonia J Vaida, M.D.     717-531-0000 ext 8434     svaida@psu.edu    
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Sonia J Vaida, MD Penn State
  More Information

No publications provided

Responsible Party: Sonia Vaida, M.D, Vice Chair for Research, Penn State University
ClinicalTrials.gov Identifier: NCT00836095     History of Changes
Other Study ID Numbers: IRB 29920
Study First Received: February 2, 2009
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
laryngeal mask, proseal

ClinicalTrials.gov processed this record on May 23, 2013