Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and Besdata Videolaryngoscopes in the Orotracheal Intubation of Children: A Non-Inferiority Randomized Clinical Trial

Airway management in infants and young children is technically challenging and carries a higher risk of complications than in older pediatric or adult patients. Achieving successful orotracheal intubation on the first attempt is particularly important in this population due to limited oxygen reserves and increased vulnerability to hypoxia, airway trauma, and hemodynamic instability. Videolaryngoscopy has been introduced as an alternative to conventional direct laryngoscopy with the potential to improve glottic visualization and intubation success. However, evidence comparing different videolaryngoscopy devices in infants remains limited, and there is currently no consensus regarding the optimal device for this age group.

Although several videolaryngoscopes are available on the market, most comparative studies have focused on adult populations. In pediatrics, and especially in infants under one year of age, published data are scarce. The McGRATH™ MAC videolaryngoscope has been more extensively studied and is widely used in clinical practice. In contrast, the BESDATA BD-DF videolaryngoscope is a newer device with very limited clinical evidence, and no head-to-head trials have compared it with other videolaryngoscopes in children. Furthermore, despite the increasing adoption of videolaryngoscopy, the economic impact of using different devices has not been adequately investigated in pediatric settings.

This study is designed to address these gaps by comparing the clinical performance and cost-effectiveness of the BESDATA BD-DF and McGRATH™ MAC videolaryngoscopes in infants undergoing elective surgery under general anesthesia. The trial will evaluate whether the BESDATA device is non-inferior to the McGRATH device in terms of intubation effectiveness while also assessing relevant economic outcomes associated with each technology.

The study will be conducted as a prospective, randomized, double-blind clinical trial at a tertiary pediatric center. Participants will be randomly allocated to undergo tracheal intubation with one of the two videolaryngoscopes. All procedures will be performed by trained anesthesiologists experienced with both devices, and data will be collected using a standardized protocol in a secure electronic database.

In addition to comparing clinical performance, the study will include an economic evaluation that considers the costs of device acquisition, required consumables, and expenses related to potential postoperative complications associated with airway management. This integrated approach aims to provide clinically meaningful and economically relevant information to support evidence-based decision-making in pediatric anesthesia.