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

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

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Intubation; Difficult or Failed; Videolaryngoscopy
• Intervention / Treatment: Device: hyperangulated videolaryngoscope; Device: Macintosh videolaryngoscope

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Martin Petzoldt, MD, Universitatsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 27, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Airway management; Hyperangulated blade; Macintosh blade
• Other Study ID Numbers: 2022-100868-BO-ff

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No