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

U

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Videolaryngoscopy
General Anesthesia
Intubation; Difficult or Failed

Treatments

Device: Macintosh videolaryngoscope
Device: hyperangulated videolaryngoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT05522049
2022-100868-BO-ff

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

182 participants in 2 patient groups

Intervention group
Experimental group
Description:
Tracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade)
Treatment:
Device: hyperangulated videolaryngoscope
Control group
Active Comparator group
Description:
Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC)
Treatment:
Device: Macintosh videolaryngoscope

Trial contacts and locations

1

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Central trial contact

Vera Köhl, MD; Martin Petzoldt, MD

Data sourced from clinicaltrials.gov

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