Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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.

Study Overview

• Status: Completed
• Conditions: Adverse Effect of Unspecified General Anesthetics
• Intervention / Treatment: Device: Supreme Laryngeal mask airway; Device: Proseal laryngeal mask airway

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • PennState Hershey Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion Time	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.	During intubation of the patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion Success Rate	Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.	During intubation of the patient

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Sonia J Vaida, MD, Penn State

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: March 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: laryngeal mask, proseal
• Other Study ID Numbers: IRB 29920