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

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed; Videolaryngoscopy; General Anesthesia
• Interventions: Device: hyperangulated videolaryngoscope; Device: Macintosh videolaryngoscope

• Registration Number: NCT05522049
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-27
• Study First Posted: 2022-08-30
• Study Start: 2022-10-17
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-24
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	hyperangulated videolaryngoscope	Tracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade)
Control group	Macintosh videolaryngoscope	Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC)

Primary Outcome Measures

Name	Time	Method
Percentage of glottic opening (POGO)	1 hour	Grading of the best view obtained during laryngoscopy (%)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany