King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy 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 first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.

Detailed Description
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The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.

Official Title
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A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

Conditions
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Tracheal Intubation

Intervention / Treatment
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* Device: Ambu King Vision Video Laryngoscope aBlade
* Device: Direct Laryngoscopy via Miller Straight Blade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anesthesiologists) I-III classified patients Patients undergoing procedure where an endotracheal tube would be normally utilized Exclusion Criteria: Children with expected difficult airways Coagulopathy

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 King Vision Video Laryngoscope aBlade System<br>The trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement. | Device: Ambu King Vision Video Laryngoscope aBlade<br>* At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.<br>* Other names: King Vision Video Laryngoscope;|
| Active Comparator: Direct Laryngoscope<br>The trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement. | Device: Direct Laryngoscopy via Miller Straight Blade<br>* At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.<br>* Other names: Miller Blade, Wisconsin blade, Straight blade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Attempt Success Rate of Tracheal Intubation | An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway. | Assessed intraoperatively at time of intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grades of Laryngeal View | Cormack Lehane (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope. | Assessed intraoperatively at time of intubation | 
| Time to Successful Intubation | The time to intubation will be measured (seconds) to measure the time to intubation of the successful attempt. | Assessed intraoperatively at time of intubation | 
| Intraoperative Complications | Airway/device related complications including, laryngospasm, bronchospasm, regurgitation/aspiration, oxygen desaturation, will be measured. | Assessed intraoperatively for the duration of the surgery | 
| Postoperative Complications | Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be measured during the post-operative period. | Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour. | 
| Ease of Endotracheal Tube Passage | The ease of tracheal tube passage will be measured following tracheal intubation. | Assessed intraoperatively at time of intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video Laryngoscopy, Tracheal intubation, Laryngoscopy