Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

NCT ID: NCT00836095

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-04-30

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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

Conditions

Adverse Effect of Unspecified General Anesthetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Supreme Laryngeal mask airway

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Proseal laryngeal mask airway

Intervention Type: DEVICE

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

Interventions

Supreme Laryngeal mask airway

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

Intervention Type: DEVICE

Proseal laryngeal mask airway

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sonia Vaida

M.D, Vice Chair for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia J Vaida, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State

Locations

PennState Hershey Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB 29920

Identifier Type: -

Identifier Source: org_study_id