Detailed statistical analysis plan for the difficult airway management DIFFICAIR trialReportar como inadecuado




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Trials

, 15:173

First Online: 15 May 2014Received: 03 January 2014Accepted: 08 May 2014DOI: 10.1186-1745-6215-15-173

Cite this article as: Nørskov, A.K., Lundstrøm, L.H., Rosenstock, C.V. et al. Trials 2014 15: 173. doi:10.1186-1745-6215-15-173

Abstract

BackgroundPreoperative 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.

Method-DesignThe 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.

ConclusionWe intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan.

Trial registrationClinicalTrials.gov: NCT01718561.

KeywordsStatistical analysis plan Cluster randomized trial Airway management Cluster analysis Difficult intubation AbbreviationsASAAmerican Society of Anesthesiologists

BMIBody Mass Index

CIconfidence interval

DADDanish Anesthesia Database

FNFalse Negative

FPFalse Positive

GCPGood Clinical Practice

ICHInternational Conference on Harmonization

ITTintention-to-treat

NNTnumber needed to treat

ROCReceiver Operating Characteristic

SARISimplified Airway Risk Index

SDstandard deviation

SPIRITStandard Protocol Items: Recommendations for Interventional Trials.

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Autor: Anders Kehlet Nørskov - Lars Hyldborg Lundstrøm - Charlotte Vallentin Rosenstock - Jørn Wetterslev

Fuente: https://link.springer.com/







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