Safety and Efficacy of the LMA Supreme When Inserted With Patients in the Prone Position

Study Overview
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Brief Summary
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This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use.

Detailed Description
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This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use. During surgery, standard treatment will be applied, complemented with the recording of study parameters related to safety, efficacy and performance of the LMA Supreme laryngeal mask airway.

Official Title
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Safety and Efficacy of the LMA Supreme Supraglottic Airway Device When Used for Adult Patients Undergoing Spinal Surgery in the Prone Position

Conditions
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Airway Obstruction

Intervention / Treatment
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* Device: LMA Supreme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 70 years of age American Society of Anesthesiology Classification (ASA) I-III patients Fasting for 8 hours Scheduled surgery with indication for laryngeal mask airway Exclusion Criteria: Have contraindicating conditions Have had radiotherapy to the neck involving the hypopharynx (risk of trauma, failure to seal effectively). Have inadequate mouth opening to permit insertion History of hiatal hernia Scheduled for minimally invasive spine stabilization procedures such as Transforaminal Lumbar Interbody Fusion (TLIF), Anterior Cervical Discectomy and Fusion (ACDF) (all have neuromonitoring/general endotracheal intubation) Scheduled for Joimax procedure (initial anesthetic is MAC) Unable to safely position themselves prone with assistance History of previous failed LMA Supreme placement BMI greater than or equal to 53 Outside age or ASA range specified in inclusion criteria Inability to comply with study requirements including follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational: LMA Supreme<br>An appropriately sized LMA Supreme will be prepared by removing all air from the cuff while applying manual pressure. A water soluble non-local anesthetic containing lubricant gel will be applied to the fully deflated airway before insertion. A 1 cm column of the gel will be preloaded into the gastric port of the LMA Supreme for the Gel Test. The cuff will be inflated with a manometer to a pressure of approximately 30cm H2O. If a significant leak is detected, the cuff will be inflated in increments of 5cm H2O until a satisfactory seal is obtained. The final cuff pressure will be recorded. The lungs will then be gently inflated by applying manual pressure to the anesthesia circuit bag while observing the gel column in the LMA Supreme gastric port for movement. | Device: LMA Supreme<br>* Placement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1 | Outcome being measured intraoperatively is the ease of manual ventilation via the LMA Supreme. Measuring, no air leaks, air leak / elevated airway pressure needed for adequate ventilation, removal and reinsertion needed to achieve adequate ventilation, no ventilation after 2 attempts (airway managed using alternative techniques | Intraoperative | 
| The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2 | Outcome being measured preoperatively and at 4 weeks +/- 5 days is the Dysphagia (difficulty swallowing) Short Questionnaire. Measuring the ability to swallow (any difficulty in swallowing), incorrect swallowing (any coughing associated with swallowing), lump feeling (any lumps in the throat), involuntary loss of weight (any weight loss recently), Pneumonia (any bouts with pneumonia). | Preoperative and up to 4 weeks (+/- 5 days) postoperative | 
| The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1 | Outcome being measured intraoperatively is any blood on the LMA upon removal. Measuring if there is minimal or no blood, blood covering less than one fourth of the LMA or blood on at least one half of the LMA surface. | Intraoperative | 
| The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1 | Outcome being measured intraoperatively is did patient develop any intraoperative episodes of laryngospasm, hiccups, or coughing. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia Short Questionnaire | Instrument used to measure difficulty swallowing (dysphagia). | Preoperative and up to 4 weeks postoperative (+/- 5 days). |