Usability and clinical performance of a low-cost 3D-printed video laryngoscope: a mixed-methods evaluation

Introduction The 3D-printed video laryngoscope (VLP-3D) offers a low-cost alternative to commercial video laryngoscopes and could increase access to airway training and clinical resources, particularly in low-resource or educational settings. However, its usability and safety must be validated to ensure clinical readiness. Objective To evaluate the usability and procedural performance of a low-cost 3D-printed videolaryngoscope (VLP-3D) compared with a commercial videolaryngoscope using a mixed-methods approach in high-fidelity simulated airway scenarios. Method A mixed-method study was conducted with 60 physicians in high-fidelity simulated settings. Each participant evaluated both devices in a randomized within-subject design using a difficult-airway manikin. Usability was assessed using heuristic evaluation, structured testing and the System Usability Scale (SUS). Objective outcomes included laryngeal visualization time, total intubation time and intubation success. Exploratory random-effects meta-analyses integrated the current findings with comparative simulation studies. Data were analysed using Spearman’s rank correlation, logistic regression, Wilcoxon signed-rank tests and meta-analysis (RevMan V.5.4). Risk of bias was assessed according to Risk of Bias in Non-randomised Studies-of Interventions and Grading of Recommendations Assessment, Development and Evaluation. Results SUS scores were high for both devices (VLP-3D, 87.01; commercial, 85.09). In the paired analysis, no statistically significant differences were observed in laryngeal visualization time (mean difference [MD], VLP-3D minus commercial = 2.51 s; 95% CI −2.22 to 7.24; p=0.293) or total intubation time (MD=−0.88 s; 95% CI −8.19 to 6.43;p=0.811). The exploratory meta-analysis likewise showed no significant pooled difference in laryngeal visualization time (MD=−1.92 s; 95% CI −12.85 to 9.00; p=0.730; I²=83.1%) or total intubation time/time to successful intubation(MD=3.15 s; 95% CI −0.95 to 7.26; p=0.132; I²=56.1%). Heterogeneity reflected differences in device design,comparator type, study design, and outcome reporting across the available simulation studies. Conclusion The VLP-3D demonstrated high perceived usability and objective procedural performance comparable to the commercial standard in high-fidelity simulated airway scenarios. It demonstrates strong clinical and educational potential for training and selective use in airway management, bridging the gap between open-source affordability and rigorous medical device standards. Further standardized preclinical evaluation and prospective clinical studies are required before patient-level safety and effectiveness can be established.