A simulation design for research evaluating safety innovations in anaesthesia*

Area of Science:

• Medical Simulation
• Patient Safety
• Anesthesiology

Background:

• Clinical randomized controlled trials are difficult for evaluating healthcare safety innovations.
• Developing effective research designs is crucial for assessing safety initiatives.

Purpose of the Study:

• To develop and evaluate a simulation-based research design for assessing safety initiatives in anesthesia.
• To identify error rates in simulated anesthesia scenarios under varying conditions.

Main Methods:

• Utilized a human-patient simulator with standard and modified scenarios.
• Modified scenarios included distractions like loud music, surgeon interference, and student questions.
• Twenty anesthetics were administered by 10 anesthesiologists to evaluate error rates.

Main Results:

• Oxygen failure scenarios had a mean of 11.3 (2.8) errors, while cardiac arrest scenarios had 8.0 (3.4) errors (p = 0.04).
• No significant difference in errors was found between standard and modified scenarios.
• An overall mean error rate of 9.7 per simulation was observed.

Conclusions:

• The developed simulation research design facilitates the evaluation of safety initiatives in anesthesia.
• Future studies with 21 subjects can achieve 80% statistical power to detect a 30% reduction in error rates.
• This methodology offers a viable approach for evidence generation in anesthesia safety research.