Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice

Study Overview
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Brief Summary
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Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation success rate, percentage of visible glottic opening (POGO score) in elective and acute clinical anaesthesiology practice.

Official Title
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Comparison of Necessary Time for Successful Intubation With the Vividtrac™ and KingVision™ Videolaryngoscopes and Macintosh Blade Direct Laryngoscopy in Clinical Practice

Conditions
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Intubation;Difficult

Intervention / Treatment
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* Device: Direct laryngoscopy
* Device: Vividtrac videolaryngoscope
* Device: KingVision videolaryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent over 18 years of age elective intervention no anticipated difficult airway or intubation preoperative anaesthesia risk assessment by American Society of Anaesthesiologists (ASA) physical status classification: ASA grade I-II Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 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

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macintosh laryngoscopy<br>In this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade. | Device: Direct laryngoscopy<br>* During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a size 4 (or size 3 if necessary) Macintosh blade direct laryngoscope.<br>|
| Active Comparator: KingVision videolaryngoscope<br>In this group intubation attempt is carried out with KingVision videolaryngoscope with a channeled, disposable single-use blade. | Device: KingVision videolaryngoscope<br>* During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.<br>|
| Active Comparator: VividTrac videolaryngoscope<br>In this group intubation attempt is carried out with VividTrac Adult model using a smartphone or laptop running the VividVision proprietary software. | Device: Vividtrac videolaryngoscope<br>* During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a Vividtrac videolaryngoscope connected to a tablet or smartphone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time necessary to secure airway during the induction of general anesthesia. Intubation time is measured from the point the airway device crosses the interdental line until the completion of intubation with insufflated cuffed endotracheal tube (secured airway). | Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngoscopy time | Time necessary to achieve best visualisation of the glottic opening. | Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt. | 
| Percentage of glottic opening (POGO) score | The POGO score describes the best view of the glottic opening compared to the anatomical picture of the glottis. During direct laryngoscopy the investigator registers an approximate socre, while video laryngoscopy records are assessed by an independent investigator. | Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt. | 
| Tube insertion time | Time necessary for the operator to insert the cuffed endotracheal tube inside the proximal part of the trachea through the glottic opening. Tube insertion time is measured after the investigator finished the search for the glottic opening, achieved best view and decided to insert the tube into the trachea until the cuff is inflated and the airway is secured. | Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt. | 
| Primary intubation attempt success rate | All intubation attempts must be finished within 120 seconds or the investigator should give up the attempt and reoxygenize the patient before another attempt. If the investigator finished within the 120 seconds time frame we assess endotracheal tube position by capnography and auscultation. The attempt is regarded successful if the tube is in the right position and the airway is secured. | Measured once after intubation. Up to 120 seconds following the start of intubation attempt. |