Effect of Standard Laryngoscopy Versus Video-laryngoscopy

Study Overview
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Brief Summary
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The aim of this open-label, randomized, 3-parallel arm trial is to compare success of intubation rate at first try between three groups that will be intubated: Conventional intubation with hyperangulated videolaryngoscope (control group), Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope, Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.

Detailed Description
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Critical anesthetic incidents in the operating room are often related to airway management. Difficult airway management is defined as the clinical situation in which an anesthesiologist with conventional training has difficulty with upper airway face mask ventilation, difficulty with tracheal intubation, or both. Airway management has undergone a major transformation since the development of hyper-angle videolaryngoscopy (VL). Recently, the ProVuTM video stylet (Flexicare Medical Ltd, Mountain Ash, UK), which combines visualization technology with a tube guidance system, has been proposed as a new device for endotracheal intubation in participants with difficult airway management. The investigators hypothesized that the ProVuTM video stylet combined with videolaryngoscopy or standard laryngoscopy may improve the success rate of intubation on the first attempt compared with using a videolaryngoscope alone in patientes with predicted difficult intubation. In fact, using ProVuTM the position of the video stylet tip can be adjusted continuously during the tracheal intubation maneuver.

Official Title
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Efferct of Standard Laryngoscopy Versus Video-laryngoscop on First-attempt Success in Difficult Airways Undergoing ProVu TM Video Stylet Guided Intubationa (PROVU)

Conditions
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Difficult Intubation

Intervention / Treatment
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* Device: Conventional intubation with hyperangulated videolaryngoscope
* Device: Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope
* Device: Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective surgery requiring oral tracheal intubation; ≥18 years of age; simplified Arné score ≥11; Written informed consent will be obtained from every participant. Exclusion Criteria: ≤18 years of age interincisor distance at maximal mouth opening ≤2 cm; planned awake fiberoptic intubation because patients are patients considered to be high-risk for difficult intubation or difficult mask ventilation (e.g. with neck tumours, complete cervical arthrodesis; neck circumference >50 cm); patients at risk of gastric aspiration planned nasal intubation.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open-label, randomized, 3-parallel arm, monocentric trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Conventional intubation with hyperangulated videolaryngoscope | Device: Conventional intubation with hyperangulated videolaryngoscope<br>* After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope<br>|
| Experimental: Provu TM video stylet + hyperangulated videolaryngoscope<br>Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope | Device: Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope<br>* After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope<br>|
| Experimental: Provu TM video stylet + Macintosh laryngoscope<br>Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope | Device: Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope<br>* After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate on first intubation attemps | The first-attempt intubation success is defined as tracheal tube placement with a single maneuver after insertion of the tube in the mouth. Reinsertion of the tube in the mouth counts as an additional attempt. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of intubation | Time from insertion of the laryngoscope beyond the dental rhyme to cuffed tube | During the procedure | 
| Time of laryngoscopy | Time from insertion of the laryngoscope beyond the dental rhyme to the insertion of the tube beyond the dental rhyme | During the procedure | 
| Number of intubation attempts | Times of reinsertion of the tube beyond the dental rhyme | During the procedure | 
| Complications | Evaluation of the type and rate of complications, including desaturation < 90%, esophageal intubation, tooth breakage and bleeding from the oropharyngeal mucosa | During the procedure | 
| Use of jaw trust or BURP | Need to perform adjuvant maneuvers (jaw trust or BURP), measured with yes/no | During the procedure | 
| Need of another anesthesiologist intervention | Required intervention of another anesthesiologist, measured with yes/no, after 3 failed intubation attempt or after request of the first anesthesiologist | During the procedure | 
| Needs to change the path of the intubation strategy | Needs to change intubation strategy, measured with yes/no, includes use of fiberoptic intubation, change of videolaryngoscope or postpone intervention | During the procedure | 
| Learning curve analysis of intubation rate success | Improvement of intubation rate success | Through study completion, an average of 1 year | 
| Learning curve analysis of time of procedure | Improvement of time of procedure | Through study completion, an average of 1 year | 

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