Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal

Study Overview
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Brief Summary
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To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Detailed Description
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Condition: The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA Proseal in paralyzed, anesthetized patients. Device: Guardian Laryngeal Mask Device: LMA Proseal Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Official Title
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Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal - A Perspective, Randomized，Blind Study

Conditions
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Efficacy of Oropharyngeal Seal Pressure

Intervention / Treatment
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* Device: Guardian Laryngeal Mask
* Device: Proseal Laryngeal Mask Airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological and general surgical under a short general paralysed anesthesia of less than 2 hours (American Society of Anesthesiologists physical status I-II) 18 to 65 years of age Mallampati score less than 3 thyromental distance more than 6.5 cm mouth opening more than >2.5 cm a body mass index less than 35 kg/m2; Exclusion Criteria: Body weight 50 Kg Pregnancy Difficult airway Recent history of upper respiratory tract infection and sore throats A history of esophageal reflux disease ENT surgery Laparoscopic surgery Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guardian<br>Device: Guardian Laryngeal Mask | Device: Guardian Laryngeal Mask<br>* Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.<br>|
| Experimental: Proseal<br>Device:Proseal Laryngeal Mask Airway | Device: Proseal Laryngeal Mask Airway<br>* Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal Seal Pressure | This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O. | 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic Position | This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O. | 5 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway Cuff, Guardian, Proseal, Cuff Pressure, laryngeal Mask Airway