Design, development, and face validation of an intubation simulation device using real‐time force data feedback

Abstract

Abstract Objectives To develop a novel laryngoscope device capable of dynamically measuring force and torque measurements in real‐time during intubation and to explore the efficacy of such a device through a face validation simulation. Methods The torque sensor laryngoscope is designed for use during intubation and is modeled after a standard, single‐use plastic laryngoscope. After device calibration, a face validation study was performed with intubation experts in the field. Quantitative data (intubation force metrics) and qualitative data (expert feedback on the device) were collected from three intubations using a Mac blade and three intubations with the Miller blade. Results Three experts (two anesthesiologists and one otolaryngologist) participated in the study. The mean maximum force exerted with the Mac blade was 24.5 N (95% confidence interval [CI], 22.3–26.8). The average force exerted was 13.6 N (95% CI, 11.7–15.5). The average total suspension time was 13.1 s (95% CI, 10.4–15.8). The average total impulse was 164.6 N·s (95% CI, 147.9–181.4). The mean maximum force exerted with the Miller blade was 31.6 N (95% CI, 26.4–36.8). The average force exerted was 15.8 N (95% CI, 13.8–17.9). The average total suspension time was 11.3 s (95% CI, 9.9–12.6). The average total impulse was 216.2 N·s (95% CI, 186.5–245.9). The mean maximum force (p = .0265) and total impulse (p = .009) were significantly higher in the Miller blade trials than in the Mac blade trials. Survey results found that this device, while bulky, intubated similarly to standard‐use models and has potential as an intubation teaching tool. Conclusion The torque sensor laryngoscope can measure and display real‐time intubation force metrics for multiple laryngoscope blades. Initial validation studies showed a significantly lower maximum force and total impulse when intubating with the Mac blade than with the Miller blade. Face validation survey results were positive and suggested the potential for this device as a teaching tool. Level of Evidence Level 5.

Keywords

• airway simulation
• biomechanical analysis
• device design
• endotracheal intubation
• face validation
• laryngoscope