• facial mask
• neonates
• sensors
• ventilation

The thesis focuses on the design and development of a non-invasive, stand-alone medical device intended to measure the forces applied during neonatal face mask ventilation. At birth, approximately one in twenty newborns requires respiratory assistance, and this number is significantly higher among preterm infants. One of the most widely used methods in such interventions is positive pressure ventilation (PPV), often administered via a facial mask. However, ensuring both the efficacy and safety of this procedure poses several challenges. If the pressure applied to the mask is insufficient, air leakage may occur, thereby reducing the effectiveness of ventilation. On the other hand, excessive pressure can stimulate the trigeminal-vagal reflex, potentially triggering apnea and bradycardia in newborns.
The core problem tackled in this project is the difficulty in maintaining the correct level of pressure on the face mask during PPV or CPAP (Continuous Positive Airway Pressure) procedures. This concern is not just theoretical—it has real implications for the clinical safety of neonates in critical care. Despite several studies addressing this issue using simulation tools and manikin-based models, there remains a significant gap in the development of practical, translatable solutions that can be used efficiently in clinical settings without cumbersome calibration processes or limitations related to mask compatibility.
The main objective of this thesis is to create a clinically viable device that can monitor the force applied during face mask ventilation without being intrusive, expensive, or overly complicated to use. Key characteristics guiding the development include biocompatibility, adaptability to different facial mask models, a simple user interface accessible to medical personnel with limited training, and ease of maintenance. The final goal is to offer a reliable plug-and-play system that integrates seamlessly into existing neonatal resuscitation workflows, improving standardization and safety.
The proposed solution is composed of two main components: a sensorized area integrated into the mask, and an electronic interface equipped with a display and a graphical user interface (GUI) developed using Arduino GIGA. The choice of Arduino as the control platform provides several advantages: it is open-source, cost-effective, and widely adopted in prototyping environments. This makes the solution not only flexible in design but also scalable for future iterations or mass production.
Several sensor technologies were evaluated during the development process, including piezoresistive, piezoelectric, and capacitive sensors. Capacitive sensors were ultimately chosen due to their excellent sensitivity, flexibility, and compatibility with soft, wearable applications. To meet the specific needs of neonatal care, the selected sensors had to support a pressure range from 0 to 100 kPa (approximately 10 Newtons), be simple to manufacture, safe for use in sensitive environments, and provide consistent and repeatable measurements.
Finally, clinical validation of the device is planned through a series of tests involving healthcare professionals in Padua. These evaluations will help confirm the device’s usability, accuracy, and potential for integration into real-world neonatal care. In conclusion, this thesis represents a comprehensive and innovative effort to develop a real-world solution for one of the most delicate procedures in neonatal medicine. By leveraging advances in flexible sensor technology, accessible hardware, and collaborative clinical design, the proposed device holds strong promise for improving patient safety and clinical outcomes for newborns requiring respiratory support at birth.