Abstract
Background
Compared to direct laryngoscopy, videolaryngoscopy (VL) can provide improved laryngeal and glottic view, higher intubation success rates in patients with a known or predicted difficult airway and reduced incidence of laryngeal/airway trauma. However, the cost and availability of these devices handicap its use in resource-restricted facilities. The objective was to design and manufacture a novel VL using additive manufacturing (AM) and evaluate its usability on an intubation manikin by comparing it to one of the most common video laryngoscopes used in clinical practice, the CMAC®, by measuring the time to first pass of the endotracheal tube as the main outcome.
Methods
A randomised cross-over study was performed with 36 anaesthetists attempting tracheal intubation of a manikin. The novel 3D-printed hyperangulated VL blade was compared to a CMAC® VL (D-blade). Participants had no prior experience or training with the novel device. The participants included consultants, registrars/trainees and medical officers in the Department of Anaesthesiology at the University of the Free State (UFS) in South Africa.
Results
The CMAC® had a statistically shorter time to first pass (median 13.8 seconds) compared to the 3D-printed model (median 19.0 seconds) (95% confidence interval [CI] 1.0–6.2; P=0.0013). No failed attempts occurred with either device.
Conclusion
Intubation times were faster with the CMAC® than with the novel device. However, with a comparable intubation success rate, 3D printing technology potentially can improve access to video laryngoscopy. Further design improvements, validation of materials and manufacturing processes are required before 3D-printed laryngoscope blades can be used in human subjects.
Data Sharing Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Acknowledgments
We would like to thank the following participating centres for their contributions to the success of this trial in the interest of advancing medical care through innovation: the Product Development and Testing Station, Central University of Technology Free State and Universitas Academic Hospital, Bloemfontein, South Africa. The authors acknowledge Dr. Daleen Struwig, medical writer/editor, Faculty of Health Sciences, UFS, for technical and editorial preparation of the article.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
The authors declare that they have no conflicts of interest.