SWIVIT - Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: Study protocol for a multicenter prospective randomized controlled trial in Switzerland

Lorenz Theiler, Kristina Hermann, Patrick Schoettker, Georges Savoldelli, Natalie Urwyler, Maren Kleine-Brueggeney, Kristopher Arheart, Robert Greif

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Background: Video-laryngoscopes are marketed for intubation in difficult airway management. They provide a better view of the larynx and may facilitate tracheal intubation, but there is no adequately powered study comparing different types of video-laryngoscopes in a difficult airway scenario or in a simulated difficult airway situation.Methods/Design: The objective of this trial is to evaluate and to compare the clinical performance of three video-laryngoscopes with a guiding channel for intubation (Airtraq™, A. P. Advance™, King Vision™) and three video-laryngoscopes without an integrated tracheal tube guidance (C-MAC™, GlideScope™, McGrath™) in a simulated difficult airway situation in surgical patients. The working hypothesis is that each video-laryngoscope provides at least a 90% first intubation success rate (lower limit of the 95% confidence interval >0.9). It is a prospective, patient-blinded, multicenter, randomized controlled trial in 720 patients who are scheduled for elective surgery under general anesthesia, requiring tracheal intubation at one of the three participating hospitals. A difficult airway will be created using an extrication collar and taping the patients' head on the operating table to substantially reduce mouth opening and to minimize neck movement. Tracheal intubation will be performed with the help of one of the six devices according to randomization. Insertion success, time necessary for intubation, Cormack-Lehane grade and percentage of glottic opening (POGO) score at laryngoscopy, optimization maneuvers required to aid tracheal intubation, adverse events and technical problems will be recorded. Primary outcome is intubation success at first attempt.Discussion: We will simulate the difficult airway and evaluate different video-laryngoscopes in this highly realistic and clinically challenging scenario, independently from manufacturers of the devices. Because of the sufficiently powered multicenter design this study will deliver important and cutting-edge results that will help clinicians decide which device to use for intubation of the expected and unexpected difficult airway.Trial registration: NCT01692535.

Original languageEnglish
Article number94
JournalTrials
Volume14
Issue number1
DOIs
StatePublished - Apr 4 2013

Fingerprint

Laryngoscopes
Switzerland
Intubation
Randomized Controlled Trials
Equipment and Supplies
Operating Tables
Laryngoscopy
Airway Management
Larynx
Random Allocation
Tongue
General Anesthesia
Multicenter Studies
Mouth
Neck
Head
Confidence Intervals

Keywords

  • A. P. Advance
  • Airtraq
  • C-MAC
  • Difficult airway
  • Glidescope
  • King vision
  • Mcgrath
  • Video-laryngoscope

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

SWIVIT - Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario : Study protocol for a multicenter prospective randomized controlled trial in Switzerland. / Theiler, Lorenz; Hermann, Kristina; Schoettker, Patrick; Savoldelli, Georges; Urwyler, Natalie; Kleine-Brueggeney, Maren; Arheart, Kristopher; Greif, Robert.

In: Trials, Vol. 14, No. 1, 94, 04.04.2013.

Research output: Contribution to journalArticle

Theiler, Lorenz ; Hermann, Kristina ; Schoettker, Patrick ; Savoldelli, Georges ; Urwyler, Natalie ; Kleine-Brueggeney, Maren ; Arheart, Kristopher ; Greif, Robert. / SWIVIT - Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario : Study protocol for a multicenter prospective randomized controlled trial in Switzerland. In: Trials. 2013 ; Vol. 14, No. 1.
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