A Comparison of Video Laryngoscopes and the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway.

Study Overview
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Brief Summary
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In Pediatric both manikin and human studies have suggested that the video laryngoscopy is equally suitable to facilitate intubation compared to the direct laryngoscopy.

Detailed Description
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The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new born and infants. In this manikin studie we want to compare different types of video laryngoscopes in a simulated normal and difficult infant airway.

Official Title
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A Comparison of the Novel King Vision Pediatric aBlade and the C-MAC Video Laryngoscope to the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway. A Bicentric, Prospective, Randomized Manikin Study

Conditions
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Airway Complication of Anesthesia

Intervention / Treatment
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* Device: normal airway
* Device: difficult airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - anesthesiologists or neonatal/pediatric intensive care medicice specialists with experience in securing pediatric airway Exclusion Criteria: - participants without experience in pediatric airway management
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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: normal airway<br>Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL) | Device: normal airway<br>* The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)<br>Device: difficult airway<br>* The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)<br>|
| Experimental: difficult airway<br>Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL) | Device: normal airway<br>* The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)<br>Device: difficult airway<br>* The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ventilation (seconds) | Three timepoints will be recorded, beginning with the insertion of the device past the theeth/gum into the mouth. These will inlcude time to best view, time to removal of device from the mouth, and the time to the first chest raising of the simulator | Assessed intraoperatively at time of intubation (seconds) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt success rate of tracheal intubation (in 40 seconds) | 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 Class) | Cormack&Lehane Grade (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope | Assessed intraoperatively at time of intubation | 
| Use of ELM | BURP or change the head/Shoulder position to optimised the glottic view will be recorded | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, laryngoscopes, pediatrics