Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial.

Area of Science:

• Anesthesiology
• Patient Safety
• Clinical Trial Methodology

Background:

• Current preoperative airway assessment in Denmark relies on non-specific clinical judgment.
• The DIFFICAIR trial aims to evaluate a systematic approach versus standard practice.
• This publication presents an updated statistical analysis plan to ensure trial transparency.

Purpose of the Study:

• To compare the frequency of unanticipated difficult airway management using a systematic airway assessment (Simplified Airway Risk Index - SARI) versus non-specific clinical assessment.
• To prevent outcome bias and selective reporting through a priori publication of the statistical analysis plan.
• To enhance transparency in data analysis for the DIFFICAIR trial.

Main Methods:

• A stratified, parallel-group, cluster-randomized multicenter trial involving 28 Danish anesthesia departments.
• Randomization to either Simplified Airway Risk Index (SARI) or usual non-specific airway assessment.
• Data collected via the Danish Anesthesia Database, with primary outcomes including the rate of unanticipated difficult and easy intubations.

Main Results:

• Data recruitment occurred from October 2012 to December 2013.
• The database registration ensures mandatory SARI use in the intervention group and masks it from controls.
• Primary outcome measures focus on the fraction of unanticipated difficult and easy intubations.

Conclusions:

• Publication of this statistical analysis plan increases the transparency of the DIFFICAIR trial's data analyses.
• A standardized approach to airway assessment is being investigated for its impact on patient safety.
• The trial protocol amendment ensures rigorous and unbiased evaluation of airway management strategies.