A Comparison of the Laryngeal Mask Airway (LMA) - Unique 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 single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.

Detailed Description
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The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). 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 will also be assessed.

Official Title
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A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-Supreme in Children

Conditions
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Laryngeal Mask Airway in Children

Intervention / Treatment
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* Device: LMA Unique: 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 Exclusion Criteria: ASA class IV, V, Emergency procedures active respiratory infection known history of difficult mask ventilation a diagnosis of a congenital syndrome associated with difficult airway management airway abnormalities (e.g., laryngomalacia, subglottic stenosis) active gastrointestinal reflux coagulopathy clinically significant pulmonary disease(s)

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 11 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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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LMA Unique<br> | Device: LMA Unique: control device<br>* LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.<br>* Other names: Laryngeal Mask Airway;|
| Active Comparator: LMA Supreme<br> | Device: LMA Supreme: comparison device<br>* LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.<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. | 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 (only in patients who receive LMA Supreme) | The ease of gastric placement will be timed and assessed using a subjective scale. The LMA Unique does not contain a gastric port so this outcome will only be assessed in patients who received the LMA Supreme device. | 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 | 
| Incidence of device repositioning and/or replacement | Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%. | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours | 
| Oropharyngolaryngeal morbidity at discharge | Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours | 
| Oropharyngolaryngeal morbidity at 24 hours post-operatively | Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. | Measured at 24 hours after device placement/study initiation |