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Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

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ClinicalTrials.gov Identifier: NCT00836095
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : June 3, 2014
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sonia Vaida, Penn State University

Study Description
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Brief Summary:

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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 or disease Intervention/treatment Phase
Adverse Effect of Unspecified General Anesthetics Device: Supreme Laryngeal mask airway Device: Proseal laryngeal mask airway Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
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. The airway device 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
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. The airway device will be blindly inserted by an experienced attending anesthesiologist.

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


Outcome Measures
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Primary Outcome Measures :
  1. Insertion Time [ Time Frame: During intubation of the patient ]
    The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.


Secondary Outcome Measures :
  1. Insertion Success Rate [ Time Frame: During intubation of the patient ]
    Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00836095


Locations
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United States, Pennsylvania
PennState Hershey Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Sonia J Vaida, MD Penn State
More Information
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Responsible Party: Sonia Vaida, M.D, Vice Chair for Research, Penn State University
ClinicalTrials.gov Identifier: NCT00836095    
Other Study ID Numbers: IRB 29920
First Posted: February 4, 2009    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: April 15, 2016
Last Verified: March 2016
Keywords provided by Sonia Vaida, Penn State University:
laryngeal mask, proseal