A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel 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 with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.

Detailed Description
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The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. 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 during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.

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

Conditions
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Laryngeal Masks in Children

Intervention / Treatment
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* Device: LMA Supreme: control device
* Device: i-gel: 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 5-50 kg age 3 months-11 years 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 Supreme<br> | Device: LMA Supreme: control device<br>* LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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: i-gel<br> | Device: i-gel: comparison device<br>* i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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 | 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 | 
| 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 | 
| 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 assesment 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 assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. | Measured at 24 hours after device placement/study initiation |