Abstract
BackgroundVideo-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/DesignThe 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.DiscussionWe 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 registrationNCT01692535
Highlights
Video-laryngoscopes are marketed for intubation in difficult airway management
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
The combination of the fiberoptic bronchoscope and the laryngoscope led to the development of video-laryngoscopes, providing a videobased view of the glottic opening, with or without additional guidance of the tube towards the tracheal opening
Summary
According to the latest national audit in anesthesia in the UK, major adverse events are estimated to be as high as 1 in 5,500 anesthesia cases, leading to brain damage and even death [1]. Airway management was deemed to be good in only 19% of these cases This is an unacceptable high failure rate for our patients’ safety. We pre-define an important clinical value as a benchmark on which all devices studied are compared with the 90% minimal first attempt success rate. KH contributed to the preparation of the study, the clinical report form, and the final protocol, designed the first draft of the manuscript, and is responsible for the organization of data acquisition as well as the coordination among the three centers (study coordinator). PS is the local principle investigator at the University Hospital of Lausanne, contributed to the final protocol and oversees the study project at that site. GS is the local principle investigator at the University Hospital of Geneva, contributed to the final protocol and oversees the study project at that site.
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