A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children

Study Overview
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Brief Summary
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The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.

Detailed Description
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The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Official Title
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A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children

Conditions
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Children

Intervention / Treatment
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* Device: LMA Proseal: control device
* Device: LMA Supreme: comparison device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing general anesthesia using a supraglottic airway device weight 10-20 kg age 6 months-6 years Exclusion Criteria: ASA class IV, V Emergency procedures History of a difficult airway Active gastrointestinal reflux Active upper respiratory tract infection

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 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 |
| --- | --- |
| LMA proseal<br> | Device: LMA Proseal: control device<br>* LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization<br>* Other names: laryngeal mask airway;|
| LMA Supreme<br> | Device: LMA Supreme: comparison device<br>* LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization<br>* Other names: laryngeal mask airway;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Leak Pressure | Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely. | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to secure the airway | From picking up the airway device to bilateral chest expansion and presence of ETCO2 | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Number of attempts to place the device | number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure) | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Fiberoptic grade of laryngeal view | The laryngeal alignment through the devices will be graded using an established scoring system | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Gastric insufflation | The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Ease of gastric tube placement | The ease of gastric placement will be timed and assessed using a subjective scale | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Fiberoptic view through the gastric tube | The view through the gastric drain tube of the LMA supreme will be assessed and graded using an established scoring system | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| feasibility of positive pressure ventilation | Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Quality of the airway | The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Adverse effects | complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded | Participants will be followed for the duration of anesthesia and 24 hours postoperatively |