Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children

Study Overview
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Brief Summary
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The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?

Detailed Description
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The aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and peri-operative complications will also be assessed.

Official Title
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A Randomized Comparison of Free-handed Fiberoptic Intubation Compared With Fiberoptic Intubation Through an Air-QTM Intubating Laryngeal Airway in Children Less Than Two Years of Age: Does Operator Experience Affect Time to Successful Tracheal Intubation?

Conditions
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Fiberoptic Intubation in Children

Intervention / Treatment
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* Device: air-Q, followed by fiberoptic intubation
* Device: Free-hand Fiberoptic Intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries Age 1 month - 2 years Weight 1-20 Kg Exclusion Criteria: Children with active respiratory infection Known history of difficult mask ventilation Diagnosis of a congenital syndrome associated with difficult airway management Airway abnormalities (e.g., laryngomalacia, subglottic stenosis).

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 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 |
| --- | --- |
| Active Comparator: Fiberoptic Intubation performed by an expert<br>Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q | Device: air-Q, followed by fiberoptic intubation<br> <br> * Other names: Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed;Device: Free-hand Fiberoptic Intubation<br>* Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed<br>|
| Experimental: Fiberoptic Intubation performed by a novice<br>Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q | Device: air-Q, followed by fiberoptic intubation<br> <br> * Other names: Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed;Device: Free-hand Fiberoptic Intubation<br>* Fiberoptic tracheal intubation will be performed without use of the air-Q 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 |
| --- | --- | --- |
| Time for successful fiberoptic tracheal intubation | The time for successful intubation will be from removal of the face mask or disconnection of the circuit from the air-Q until evidence of end-tidal CO2 is 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 |
| --- | --- | --- |
| Time to successful placement of the Air-Q | Successful placement of the air-Q will start with the removal of the facemask until presence of end-tidal CO2 is confirmed. | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | 
| Number of attempts to place the Air-Q | 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 | 
| Ease for placement of the air-Q | The ease for Air-Q placement will be assessed using a subjective scale | 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 | 
| Peri-operative complications | Includes: Complications during the placement of the Air-Q (Laryngospasm, Bronchospasm, Desaturation, etc. Oropharyngolaryngeal morbidity at discharge, participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours. Oropharyngolaryngeal morbidity at 24 hours post-operatively, measured at 24 hours after device placement/study initiation. These will be 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 | 
| Number of attempts for fiberoptic tracheal intubation | Number of attempts needed for successful fiberoptic tracheal intubation 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 | 
| Ease for fiberoptic tracheal intubation | The ease for fiberoptic tracheal intubation will be assessed using a subjective scale | 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, tracheal intubation, fiberoptic bronchoscopy