Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit 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 whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.

Detailed Description
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The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.

Official Title
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Prospective Randomized Comparison of the Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

Conditions
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Tracheal Intubation in Children

Intervention / Treatment
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* Device: Ambu Aura-i size 1.5
* Device: air-Q ILA size 1.5
* Device: Ambu Aura-i size 2
* Device: air-Q ILA size 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing general anesthesia requiring tracheal intubation Weight 5-20 kg Age one month-six years Exclusion Criteria: ASA class IV, V Emergency procedures History of a difficult airway Active upper respiratory tract infection Children receiving emergent surgery

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: Ambu Aura-i size 1.5<br>patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight | Device: Ambu Aura-i size 1.5<br>* Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed<br>|
| Experimental: air-Q size 1.5<br>patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight | Device: air-Q ILA size 1.5<br>* Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed<br>|
| Experimental: Ambu Aura-i size 2<br>patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight | Device: Ambu Aura-i size 2<br>* Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed<br>|
| Experimental: air-Q size 2<br>patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight | Device: air-Q ILA size 2<br>* Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease and time to successful tracheal intubation | from the time of fiberoptic bronchoscope entry into the device until positive clinical signs indicating successful tracheal intubation (i.e., presence of bilateral breath sounds, appropriate end-tidal CO2) are confirmed | 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 and time to place 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 supraglottic device and tracheal tube | number of attempts needed for successful placement will be recorded (maximum of 3 attempts; >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 | 
| 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 completely | 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 | 
| Time to remove device | removal will be done with the use of a removal stylet. Should inadvertent extubation occur during removal of the device, the intubation will be deemed a failure. | 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 various airway maneuvers such as jaw thrust, neck extension, advancement/ withdrawal of the supraglottic device, and/ or anterior Laryngeal Pressure to optimize tracheal intubation will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Adverse effects | complications such as oxygen desaturations, inadvertent extubation, tracheal pilot balloon breakage, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded | 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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laryngeal mask airway, children, tracheal intubation, fiberoptic bronchoscopy