Clinical trial NCT05522049: Videolaryngoscopic Intubation Using Macintosh vs.Hyperangulated Blades in Patients With Expected Difficult Intubation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Videolaryngoscopy
General Anesthesia
Keywords: Airway management
Hyperangulated blade
Macintosh blade
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of glottic opening (POGO)
timeFrame: 1 hour
Secondary outcomes:
measure: Time to successful tracheal intubation (seconds)
timeFrame: 1 hour
measure: Time to successful first attempt intubation (seconds)
timeFrame: 1 hour
measure: Cormack-Lehane grade
timeFrame: 1 hour
measure: Impaired view (vocal cords cannot be visualized by laryngoscopy)
timeFrame: 1 hour
measure: Difficult laryngoscopy
timeFrame: 1 hour
measure: Difficult intubation
timeFrame: 1 hour
measure: Transition to a different tracheal intubation technique
timeFrame: 1 hour
measure: Tracheal introducer
timeFrame: 1 hour
measure: Successful first attempt
timeFrame: 1 hour
measure: Overall success of intubation
timeFrame: 1 hour
measure: Difficulty of videolaryngoscope-guided intubation
timeFrame: 1 hour
measure: Number of intubation attempts
timeFrame: 1 hour
measure: Number of laryngoscopy attempts
timeFrame: 1 hour
measure: Airway related adverse events
timeFrame: 1 hour
measure: Hypoxaemia
timeFrame: 1 hour
measure: Hypotension
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: PRINCIPAL_INVESTIGATOR
References: