Development and evaluation of the Frankfurt Intubation Device, a user-centred design for enhanced patient safety

Background Endotracheal intubation can be a lifesaving procedure but poses risks, particularly in emergency situations. Inexperienced users benefit from user-friendly devices for successful intubation. Methods This feasibility study assessed the Frankfurt Intubation Device (FID), developed for ease of use with early aspiration protection and a redundant light source. 30 medical students with minimal intubation experience were randomised to start with endotracheal tube (ET)+stylet or FID. After standardised instruction, each performed one manikin intubation per device. Usability was assessed on a 10-point Likert scale (1–10), with lower scores indicating better usability. Results Participants rated the FID as easy to use (median (Md)=3 (2;3)) and suitable for everyday practice (Md=3 (2;4)). They preferred the FID (Md=3 (2;4)) and believed it could become a new standard, requiring minimal training (Md=2 (1.25;3)) while enhancing safety (Md=2 (2;3)). No significant difference in preference was found between FID and ET+stylet. Time to airway protection was 13 (11;16.5) s and 13 (11.5;20) s for ET+stylet, and 16 (13;19.5) s and 14 (12;15.5) s for FID. Time to ventilation increased for ET+stylet from 18 (16.5;23) s to 20 (18;28) s, but decreased for FID from 38 (34.5;46) s to 34 (30.5;38) s. All participants succeeded on the first attempt without dental trauma. Conclusion The FID is easy to use, requires minimal training and shows strong acceptance. The time to ventilation was slower than with ET+stylet in this manikin model but may improve in difficult airways. An industry cooperation is aspired.