Usability and Clinical Performance of a Low-Cost 3D-Printed Video Laryngoscope: A Mixed-Methods Evaluation

Published: 12 December 2025| Version 1 | DOI: 10.17632/dddwx5wvnx.1
Contributors:
Ana Cristina Kraemer Moraes,
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Description

This study demonstrates that a low-cost, 3D-printed videolaryngoscope can achieve usability and safety outcomes comparable to a commercial gold-standard device in both simulated and clinical usability environments. It also introduces a replicable, structured evaluation model aligned with international human factors and regulatory standards.

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Following international standards (FDA, 2016; ISO, 2015; ABNT, 2010; AAMI, 2009; Zhang et al., 2003). All analyses were conducted using PSPP version 2.0.0 (GNU PSPP, 2024; Gordon & Finch, 2012). Meta-analyses were conducted using Review Manager 5.4 (RevMan; The Cochrane Collaboration, 2020) . The study protocol was evaluated according to the ROBINS-I (Sterne et al., 2016) and GRADE (Guyatt et al., 2011) frameworks. This study was approved by the Ethics Committee of the Catholic University of Pelotas (CAAE: 59663522.70000.5339) and authorized by the research ethics boards of all participating institutions. All participants provided written informed consent, and the study adhered to the Brazilian National Health Council’s Resolution No. 466/2012 and the Declaration of Helsinki on ethical principles for research involving human subjects.

Institutions

Categories

Ergonomics, Usability Engineering, Airway Device

Funders

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