Abstract
IntroductionMost trials comparing effectiveness of laryngoscopy technique use surrogate endpoints. Intubation success is a more appropriate endpoint for comparing effectiveness of techniques or devices. A large pragmatic clinical trial powered for intubation success has not yet been performed.MethodsWe tested the feasibility of a randomised controlled trial to compare the performance of direct laryngoscopy versus videolaryngoscopy for endotracheal intubation. The trial was conducted in the Department of Adult and Emergency Anaesthesia at the Auckland City Hospital, New Zealand. Patients over 18 years who required endotracheal intubation and were not known or predicted to be difficult to bag-mask ventilate were eligible for the study. Patients were excluded if they required rapid sequence induction, fibreoptic intubation or were unable to consent due to language barriers or cognitive impairment.Patients were permuted block randomised in groups of 8 to either direct laryngoscopy (DL) or videolaryngoscopy (VL) for the technique of endotracheal intubation. Patients were blinded to laryngoscopic technique; the duty anaesthetist, outcome assessors and statistician were unblinded.Feasibility was assessed on recruitment rate, adherence to group assignment and data completeness. Primary outcome was first-pass success rate, with secondary outcomes of time to intubation (seconds), Intubation Difficulty Score and complication rate.ResultsOne hundred and six patients were randomised and 100 patient results were analysed. Completed data from patients randomised to the DL group (n = 49) was compared with those in the VL group (n = 51). Group adherence and data completeness were 100% and 97%, respectively. First-pass success rate was 83.7% in the direct laryngoscopy group and 72.5% in the videolaryngoscopy group (p = 0.18). Median time to intubation was significantly shorter for direct laryngoscopy when compared to videolaryngoscopy (34 s v 43 s, p = 0.038). Complications included mucosal trauma and airway bleeding which are recognised complications of endotracheal intubation.ConclusionA large, pragmatic, multicentre, randomised controlled trial comparing the relative effectiveness of direct laryngoscopy and indirect videolaryngoscopy is feasible.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12615001267549
Highlights
Most trials comparing effectiveness of laryngoscopy technique use surrogate endpoints
The trial was designed to assess the feasibility of undertaking a larger pragmatic effectiveness trial examining the success rate of a videolaryngoscopy (VL) technique when compared to direct laryngoscopy (DL)
The factors leading to delaying the recruitment target could be avoided in a larger trial, as there would be adequate resource allocation to facilitate this
Summary
Most trials comparing effectiveness of laryngoscopy technique use surrogate endpoints. Most trials comparing effectiveness of laryngoscopy technique use surrogate endpoints such as laryngoscopic view or Intubation Difficulty Score. Intubation success is a more appropriate endpoint for comparing effectiveness of techniques or devices. In trials recording failed intubation, there is much heterogeneity in this definition, which makes drawing clear conclusions difficult [4]. We believe the most meaningful endpoint to determine the performance of these devices is first-pass intubation success. Meta-analyses comparing these devices have amalgamated small trials using surrogate primary endpoints and have rarely collected data relating to harm that could be consequent to their use [13,14,15]. Evidence relating to different videolaryngoscopic techniques, such as direct versus indirect videolaryngoscopy, require further examination, as devices with different designs are unlikely to perform [4]
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call