Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

Phase 4

Completed

• Conditions: Adverse Effect of Unspecified General Anesthetics
• Interventions: Device: Supreme Laryngeal mask airway; Device: Proseal laryngeal mask airway

• Registration Number: NCT00836095
• Lead Sponsor: Milton S. Hershey Medical Center

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-04
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Results First Submitted: 2014-05-05
• Results First Submitted QC: 2014-05-05
• Results First Posted: 2014-06-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-17
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supreme LMA	Supreme Laryngeal mask airway	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.
Proseal LMA	Proseal laryngeal mask airway	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.

Primary Outcome Measures

Name	Time	Method
Insertion Time	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

Name	Time	Method
Insertion Success Rate	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.

Trial Locations

Locations (1)

PennState Hershey Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States