文章基本信息

标题：Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial
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作者：Anders Kehlet Nørskov ; Lars Hyldborg Lundstrøm ; Charlotte Vallentin Rosenstock 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2014
卷号：15
期号：1
页码：173
DOI：10.1186/1745-6215-15-173
语种：English
出版社：BioMed Central
摘要：Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist. The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management. To prevent outcome bias and selective reporting, we hereby present a detailed statistical analysis plan as an amendment (update) to the previously published protocol for the DIFFICAIR trial. The DIFFICAIR trial is a stratified, parallel group, cluster (cluster = department) randomized multicenter trial involving 28 departments of anesthesia in Denmark randomized to airway assessment either by the Simplified Airway Risk Index (SARI) or by a usual non-specific assessment. Data from patients’ preoperative airway assessment are registered in the Danish Anesthesia Database. An objective score for intubation grading the severity, that is the severity of the intubations, as well as the frequency of unanticipated difficult intubation, is measured for each group. Primary outcome measures are the fraction of unanticipated difficult and easy intubations. The database is programmed so that the registration of the SARI is mandatory for the intervention group but invisible to controls. Data recruitment was commenced in October 2012 and ended in ultimo December 2013. We intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan. ClinicalTrials.gov: NCT01718561 .
关键词：Statistical analysis plan ; Cluster randomized trial ; Airway management ; Cluster analysis ; Difficult intubation