The Safety and Efficacy of Supraglottic Airway Use in Children

Study Overview
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Brief Summary
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This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.

Detailed Description
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This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital. Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected. The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.

Official Title
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The Safety and Efficacy of Supraglottic Airway Use in Children

Conditions
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Supraglottic Airway Use in Children

Intervention / Treatment
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* Device: Supraglottic Airway Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation & ventilation Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 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 |
| --- | --- |
| Supraglottic Airway Device<br>Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines | Device: Supraglottic Airway Device<br> <br> * Other names: I-Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supraglottic Airway Device Failure | Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation | 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 |
| --- | --- | --- |
| Ease of Placement of Supraglottic Airway Device | Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult) | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Multiple Attempts to Place Supraglottic Airway Device | change in device, placement method, and provider will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Airway Maneuvers/interventions | the number and type of airway maneuvers performed after device placement and during maintenance will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Occurrence of Inadequate Ventilation | cause and solution for inadequate ventilation will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Intraoperative Complications | Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie. dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Postoperative Complications | Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness | participants will be followed for the duration of anesthesia and 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraglottic airway, children, safety, efficacy