Videolaryngoscopic Intubation Using Macintosh vs.Hyperangulated Blades in Patients With Expected Difficult Intubation

Study Overview
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Brief Summary
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Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.

Official Title
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Videolaryngoscopy-guided Intubation Using Macintosh Versus Hyperangulated Blades in Patients With Expected Difficult Intubation Undergoing Ear, Nose and Throat Surgery or Maxillofacial Surgery a Randomized Controlled Trial

Conditions
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Intubation; Difficult or Failed, Videolaryngoscopy, General Anesthesia

Intervention / Treatment
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* Device: hyperangulated videolaryngoscope
* Device: Macintosh videolaryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery Expected difficult intubation Age ≥ 18 Exclusion Criteria: Pregnant or breastfeeding woman Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents) Required transnasal tracheal intubation (e.g. for surgical reasons) Special tubes required for surgical reasons ( e.g. double lumen tube) Denial of consent

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: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Tracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade) | Device: hyperangulated videolaryngoscope<br>* Intubation using a hyperangulated videolaryngoscope<br>* Other names: Storz;|
| Active Comparator: Control group<br>Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC) | Device: Macintosh videolaryngoscope<br>* Intubation using a Macintosh videolaryngoscope<br>* Other names: Storz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of glottic opening (POGO) | Grading of the best view obtained during laryngoscopy (%) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to successful tracheal intubation (seconds) | Recorded during airway management | 1 hour | 
| Time to successful first attempt intubation (seconds) | Recorded during airway management | 1 hour | 
| Cormack-Lehane grade | Grading of the best view obtained during laryngoscopy (I [best] to IV [worst]) | 1 hour | 
| Impaired view (vocal cords cannot be visualized by laryngoscopy) | Number of participants with impaired view observed during airway management | 1 hour | 
| Difficult laryngoscopy | Number of participants with difficult laryngoscopy as defined in current guidelines | 1 hour | 
| Difficult intubation | Number of participants with difficult tracheal intubation as defined in current guidelines | 1 hour | 
| Transition to a different tracheal intubation technique | Number of participants in whom the airway operator decided to convert to an alternative intubation technique | 1 hour | 
| Tracheal introducer | Number of participants in whom the airway operator decided to use a tracheal introducer | 1 hour | 
| Successful first attempt | Number of participants with successful tracheal intubation with only one attempt | 1 hour | 
| Overall success of intubation | Number of participants with successful tracheal intubation regardless of the the number of attempts | 1 hour | 
| Difficulty of videolaryngoscope-guided intubation | VIDIAC (Videolaryngoscopic Intubation and Difficult Airway Classification) Score from -1 (best) to 5 (worst) | 1 hour | 
| Number of intubation attempts | Observed during airway management | 1 hour | 
| Number of laryngoscopy attempts | Observed during airway management | 1 hour | 
| Airway related adverse events | Number of participants with airway related adverse events observed during airway management | 1 hour | 
| Hypoxaemia | Number of participants with a drop in peripheral oxygen saturation during airway management | 1 hour | 
| Hypotension | Number of participants with hypotension observed during airway management | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway management, Hyperangulated blade, Macintosh blade