A Comparison of the LMA Unique and LMA Supreme in Children

Study Overview
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Brief Summary
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The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Detailed Description
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The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal. The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Official Title
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A Prospective, Randomized Comparison of the LMA Unique and LMA Supreme in Children

Conditions
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Children

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing general anesthesia using a supraglottic airway device weight 10-25kg 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 Supreme<br> | |
| LMA unique<br> | |

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. | after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fiberoptic grade of laryngeal view | The laryngeal alignment through the devices will be graded using an established scoring system | After placement of the supraglottic device | 
| Adverse effects | complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded | Participants will be followed 24 hours postoperatively | 
| Time to secure the airway | From picking up the airway device to bilateral chest expansion and presence of ETCO2 | after placement of the supraglottic airway device | 
| Number of attempts to place the device | number of attempts needed for successful placement will be recorde (maximum of 3 attempts will be considered as a failure) | at the beginning of anesthesia | 
| 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 | After placement of the LMA supreme | 
| Ease of gastric tube placement | The ease of gastric placement will be assessed using a subjective scale | After placement of the LMA supreme | 
| Gastric insufflation | The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation | During leak pressure testing | 
| Quality of the airway | The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale | During maintenance of anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraglottic airway devices in children