Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.

Detailed Description
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The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be performed by residents in training. The primary outcome is of time for successful tracheal intubation. The investigators hypothesize that residents will intubate the trachea faster when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic airway device, fiberoptic grade of laryngeal view, time for device removal after intubation, and peri-operative complications will also be assessed.

Official Title
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A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children

Conditions
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Tracheal Intubation in Children

Intervention / Treatment
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* Device: i-gel
* Device: air-Q


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing general anesthesia requiring tracheal intubation Age one month to six years Exclusion Criteria: ASA class IV, V Children receiving emergent surgery History or high suspicion of a difficult airway Active upper respiratory tract infection

Ages Eligible for Study
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Minimum Age: 1 Month
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: air-Q<br>Patients will receive the air-Q with size based on manufacturer recommendations of body weight | Device: air-Q<br>* Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.<br>|
| Experimental: i-gel<br>Patients will receive the i-gel with size based on manufacturer recommendations of body weight | Device: i-gel<br>* Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Successful Tracheal Intubation | Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful 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 | Ease of placement of supraglottic 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 | 
| Number of Attempts to Place the Supraglottic Device | Number of attempts will be limited to 3 | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Supraglottic Airway Leak Pressure | The airway pressure at which an airway leak is observed after placement of the supraglottic airway | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Fiberoptic Grade of Laryngeal View | Fiberoptic Grade of Laryngeal View through either the air Q or i-gel will be graded using a previously published grading system | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Airway Maneuvers | The number and type of airway maneuvers performed during tracheal intubation 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 the airway, such as sore throat or hoarseness. | Participants will be followed for the duration of anesthesia and 24 hours postoperatively | 
| Time to Placement of Supraglottic Airway | Time to placement of supraglottic device will be measured. | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Number of Attempts to Place the Tracheal Tube | Number of attempts to place the tracheal tube via fiberoptic bronchoscopy through supraglottic device will be limited to 3 | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraglottic airway, children, fiberoptic guided tracheal intubation, air-Q, i-gel