Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Tracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade) |
|
| Control group | Active Comparator | Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperangulated videolaryngoscope | Device | Intubation using a hyperangulated videolaryngoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of glottic opening (POGO) | Grading of the best view obtained during laryngoscopy (%) | 1 hour |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Petzoldt, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
Not provided
Randomized controlled trial
Not provided
Not provided
Not provided
| Macintosh videolaryngoscope | Device | Intubation using a Macintosh videolaryngoscope |
|
|
| 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 |