KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope performs as well as direct laryngoscopy for intubating small children and infants.

Detailed Description
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The goal of this prospective randomized study is to compare the Ambu KingVision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. The primary outcome of the study will be time to successful intubation. Other outcomes of clinical relevance such as first attempt success rates of intubation, grade of laryngeal view, percentage of glottic opening, number of insertion attempts, hemodynamic responses, and complications will also be assessed.

Official Title
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A Clinical Evaluation of the King Vision Video Laryngoscope aBlade System in Children

Conditions
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Tracheal Intubation

Intervention / Treatment
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* Device: Ambu KingVision Video Laryngoscope aBlade
* Device: Miller Direct Laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at Lurie Children's Hospital undergoing surgery/procedure where intubation is indicated American Society of Anesthesiology Class I-III patients Exclusion Criteria: Children with an expected difficult airway A bleeding or blood clotting disorder

Ages Eligible for Study
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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: Direct Laryngoscopy<br>The trachea will be intubated via direct laryngoscopy using a traditional straight blade (Miller) laryngoscope. | Device: Miller Direct Laryngoscopy<br>* At time of tracheal intubation, the subject will be intubated using a Miller blade laryngoscope. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.<br>|
| Experimental: KingVision Video Laryngoscope<br>The trachea will be intubated using the Ambu KingVision Video Laryngoscope size 1 pediatric blade. | Device: Ambu KingVision Video Laryngoscope aBlade<br>* At time of tracheal intubation, the subject will be intubated using the Ambu KingVision Video Laryngoscope with a size 1 aBlade. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation | Three timepoints will be recorded, beginning with insertion of the device past the lips into the mouth. These will include time to optimal glottic view, time to removal of device from mouth, and time to first CO2 capnography upstroke. The primary outcome measure will be total time to intubation, as the sum of all three timepoints. | Assessed intraoperatively at time of intubation | 

Secondary 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 | 
| 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 | 
| Intubation Adjustments & Ease of Use | Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation. | Assessed intraoperatively following intubation | 
| Hemodynamic Parameters - Heart Rate | Heart rate (beats per minute) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation. | Assessed intraoperatively at time of and following intubation | 
| Hemodynamic Parameters - Blood Pressure | Blood pressure (mmHg) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation. | Assessed intraoperatively at time of and following intubation | 
| Intraoperative Complications | Airway/device related complications including, laryngospasm, bronchospasm, oxygen desaturation, will be assessed at intubation, during the surgery, and after extubation while under the anesthesiologists care. | Assessed intraoperatively | 
| Postoperative Complications | Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be assessed in the post anesthesia care unit. | Assessed postoperatively while admitted to the phase 1 recovery unit, approximately 30-60 minutes after surgery | 

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