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

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05522049
• Other study ID #: 2022-100868-BO-ff
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Intubation; Difficult or Failed
• Videolaryngoscopy

Intervention

Device:
• hyperangulated videolaryngoscope
Intubation using a hyperangulated videolaryngoscope
• Macintosh videolaryngoscope
Intubation using a Macintosh videolaryngoscope

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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