A Comparison of the Ambu AuraGain Versus LMA Supreme in Children

Study Overview
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Brief Summary
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The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.

Detailed Description
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The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.

Official Title
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A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children

Conditions
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Supraglottic Airway

Intervention / Treatment
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* Device: Ambu AuraGain (size 1.5 or size 2.0)
* Device: LMA Supreme (size 1.5 or size 2.0)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for surgery utilizing a supraglottic airway device ASA (American Society of Anesthesiologists) I-III classification Weighing between 5 - 20 kilograms Exclusion Criteria: Active respiratory infection History of difficult mask ventilation Diagnosis of congenital syndrome with difficult airway management Active gastrointestinal reflux Coagulopathy Significant Pulmonary disease Emergent surgery

Ages Eligible for Study
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Minimum Age: 3 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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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambu AuraGain<br>Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines | Device: Ambu AuraGain (size 1.5 or size 2.0)<br>* The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.<br>* Other names: Ambu AuraGain;|
| Active Comparator: LMA Supreme<br>Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines | Device: LMA Supreme (size 1.5 or size 2.0)<br>* The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.<br>* Other names: LMA Supreme;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal (airway) leak pressure - Initial | The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway | Assessed intraoperatively at the time of confirmed device placement | 
| Oropharyngeal (airway) leak pressure - 10 Minutes | The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway | Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Successful Placement of the Supraglottic Airway | Time for successful placement of supraglottic device will be recorded | Assessed intraoperatively at the time of confirmed device placement | 
| Number of attempts to placement of Supraglottic Airway | Number of attempts and insertion techniques will be recorded (maximum of 3 attempts) | Assessed intraoperatively at the time of confirmed device placement | 
| Fiberoptic Grade of Laryngeal View through Supraglottic Airway | Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system | Assessed intraoperatively at the time of confirmed device placement | 
| Gastric Tube Insertion Ease of Placement | The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube. | Assessed intraoperatively at the time of confirmed gastric tube placement | 
| Gastric Tube Insertion Time | The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope. | Assessed intraoperatively at the time of confirmed gastric tube placement | 
| Gastric Tube Insertion Attempts | Number of insertion attempts of the gastric tube through the SGA will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope. | Assessed intraoperatively at the time of confirmed gastric tube placement | 
| Postoperative Complications | Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period. | Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit. | 
| Intraoperative Complications | Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur. | Assessed intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraglottic airway, Laryngeal mask airway, Children