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

NCT05522049 | Completed

• 1 other identifier: 2022-100868-BO-ff
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed; Videolaryngoscopy; General Anesthesia

Keywords

Airway management; Hyperangulated blade; Macintosh blade

Outcome Measures

Primary Outcomes (1)

• Percentage of glottic opening (POGO)

  Grading of the best view obtained during laryngoscopy (%)

  1 hour

Secondary Outcomes (16)

• Time to successful tracheal intubation (seconds)

  1 hour

• Time to successful first attempt intubation (seconds)

  1 hour

• Cormack-Lehane grade

  1 hour

• Impaired view (vocal cords cannot be visualized by laryngoscopy)

  1 hour

• Difficult laryngoscopy

  1 hour

Study Arms (2)

Intervention group

EXPERIMENTAL

Tracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade)

Device: hyperangulated videolaryngoscope

Control group

ACTIVE COMPARATOR

Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC)

Device: Macintosh videolaryngoscope

Interventions

hyperangulated videolaryngoscope DEVICE

Intubation using a hyperangulated videolaryngoscope

Also known as: C-MAC D-Blade, Storz

Intervention group

Macintosh videolaryngoscope DEVICE

Intubation using a Macintosh videolaryngoscope

Also known as: C-MAC, Storz

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery
• Expected difficult intubation
• Age ≥ 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Study Officials

• Martin Petzoldt, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: October 17, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

DE (1)