Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

Study Overview
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Brief Summary
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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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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.

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

Conditions
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Adverse Effect of Unspecified General Anesthetics

Intervention / Treatment
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* Device: Supreme Laryngeal mask airway
* Device: Proseal laryngeal mask airway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Supreme LMA<br>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<br>* Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant<br>|
| Active Comparator: Proseal LMA<br>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<br>* Proseal is a multiple use, variant of the laryngeal mask airway<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal mask, proseal