Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

Penn State Health

Status and phase: Completed; Phase 4

Conditions: Adverse Effect of Unspecified General Anesthetics

Treatments: Device: Supreme Laryngeal mask airway; Device: Proseal laryngeal mask airway

Study type: Interventional

Funder types: Other

Identifiers

NCT00836095

IRB 29920

Details and patient eligibility

About

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Supreme LMA

Other group

Description:

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.

Treatment:

Device: Supreme Laryngeal mask airway

Proseal LMA

Active Comparator group

Description:

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.

Treatment:

Device: Proseal laryngeal mask airway