Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial - trial protocol for a cluster randomized clinical trial.

Background: Pre-operative airway assessment in Denmark is based on a non-specific clinical assessment. Systematic, evidence-based and consistent airway assessment may reduce the incidence of unanticipated difficult airway management. By assessing multiple predictors for difficult airway management, the predictive value of the assessment increases. The Simplified Airway Risk Index (SARI) is a multivariate risk score for predicting difficult intubation.This study aims to compare the use of the SARI with a non-specified clinical airway assessment on predicting difficult intubation. Further, to compare the examination and registration of predictors for difficult mask ventilation with a non-specified clinical airway assessment on prediction of difficult mask ventilation.

Method/design: We cluster-randomized 28 Danish departments of anaesthesia to airway assessment either by the SARI or by usual non-specific assessment. Data from patients' pre-operative airway assessment are registered in the Danish Anaesthesia Database. Objective scores for intubation and mask ventilation grade the severity of airway managements. The accuracy of predicting difficult intubation and mask ventilation is measured for each group. The primary outcome measure is the fraction of unanticipated difficult and easy intubation.The fraction of unanticipated difficult intubation in Denmark is 1.87%. With a stratified randomization, type 1 error risk of 5% and a power of 80%, 30 departments are required to detect or reject a 30% relative risk reduction equalling a number needed to treat of 180. Sample size estimation is adjusted for the study design and based on standards for randomization on cluster-level. With an average cluster size of 2,500 patients, 70,000 patients will be enrolled over a 1-year trial period. The database is programmed so that registration of the SARI and predictors for difficult mask ventilation are mandatory for the intervention group but invisible to controls.

Discussion: It is innovative to use a national clinical database as the basis for a randomized clinical trial. The method can serve as a precedent for implementation of evidence-based recommendations and database registration.The trial will forward understanding of how to predict and reduce unanticipated difficult airways and how to produce evidence-based recommendations for airway assessment and clinical database development.

Trial Registration: (NCT01718561).