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Validation, certification and commercial launch of the module for non-invasive measurement of tidal volume by electrical impedance tomography, for patients undergoing artificial ventilation

Grant number: 18/22439-8
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: July 01, 2019 - June 30, 2021
Field of knowledge:Engineering - Biomedical Engineering - Medical Engineering
Cooperation agreement: FINEP - PIPE/PAPPE Grant
Principal Investigator:Eduardo Moscatelli de Souza
Grantee:Eduardo Moscatelli de Souza
Company:Timpel S/A
City: São Paulo
Assoc. researchers: Carolina Eimi Kajiyama ; Felipe de Souza Rossi ; Letícia Candançan Corrêa

Abstract

The project comprises the validation, certification and commercial launch in Brazil and Europe of a non-invasive module for measuring Tidal Volume by Electrical Impedance Tomography, for patients submitted to an artificial ventilatory support. The use of High Flow Ventilation (HFV) is already a widespread therapy for pediatric and neonatal patients. In adults, HFV appears to perform better than non-invasive ventilation in hypoxemic respiratory failure. Practical and non-invasive, HFV is generally well tolerated, but is limited in terms of monitoring the volumes of gases that reach the lungs of patients during treatment. This volume depends, for example, on the anatomy and position of the patient's mouth. Patients with Acute Respiratory Distress Syndrome (ARDS) can easily harm themselves by generating high inspiratory pressures and high Tidal Volumes, called Self-Inflicted Lung Injury (SILI).The Tidal Volume is one of the most important ventilatory parameters adjusted by caregivers at the bedside. However, the measurement made by ventilators is very imprecise for pediatric and neonatal patients due to an intentional leak in the endotracheal tube and also because of the lack of proximal flow sensor in most ventilators. Higher than needed Tidal Volumes contributes most to the risk of Ventilatory induced Lung Injury (VILI), which increases morbidity, mortality rate and treatment cost. A tidal volume smaller than necessary can cause hypoventilation and hypercapnia. In short, an adequate titration of the High Flow Ventilation Therapy depends on the constant measurement of the Tidal Volume that is being imposed on the patient's lung. The continuous measurement of Tidal Volume in intubated neonates and pediatric patients is required for adjustment of ventilatory parameters, reducing the likelihood of complications, the risk of adverse events (such as VILI and SILI) and therefore the cost of the treatment. The project consists in the validation, certification and commercialization in Brazil and Europe of a non-invasive module for measuring Tidal Volume, incorporated into the Electrical Impedance Tomography already marketed by Timpel. The methodology for the development of the project fulfills the standards for medical devices, which covers the phases from planning to market surveillance. The project encompasses seven intermediate objectives, culminating in the commercial launch of the product, which involves the incorporation of the algorithm to the tomograph, validation, improvement, graphical user interface, conducting clinical studies, certification and commercial presentations in congresses. It is estimated that within 5 years more than 20% of the patients will be submitted to High Flow Ventilation therapy, and that less than 30% of the neonatal and pediatric patients have their Tidal Volume monitored by the ventilator (which, noteworthy, presents measurement with errors greater than 30%). This project, in addition to a clinically useful decision making tool for a better mechanical ventilation, should result in a net profit of R$ 1.5 million within one year after the launch, and R$ 7 million in the fourth year. (AU)