Industrial and commercial development of electrical impedance tomography for neonates

Abstract

The objective of the project is the industrial development and commercial launch in Brazil and Europe of the Electrical Impedance Tomography device for neonates. The Electrical Impedance Tomograph (EIT) is a non-invasive, radiation-free medical device used at the bedside in Intensive Care Units that allows real-time assessment of the regional distribution of ventilation, and identification of phenomena such as collapse and pulmonary hyperdistension. The information provided by the device allows a more adequate and individualized management of ventilatory support - currently for adult and pediatric patients. The global average of premature births in 2010 was 11.1% of live births, which means 14.9 million premature babies. Brazil ranked tenth in the ranking of countries with the highest preterm birth rates in 2010, with 9.2% of live births this year, or a total of 279,256 premature infants. Complications related to preterm birth - such as infections, respiratory and renal failure - account for approximately 35% of the 3.1 million neonatal deaths annually. Prematurity is the leading cause of death among children under five years of age, representing a total of about one million deaths in 2013.Premature birth, with the onset of exposure to oxygen concentrations not anticipated in intrauterine development, associated with the need for artificial mechanical ventilation, leads to a process of pulmonary aggression, resulting in a blockage of pulmonary development in its sacular stage, known as bronchopulmonary dysplasia. Because of its frequency and severity, bronchopulmonary dysplasia is one of the central concerns of the neonatologist in ventilatory support to preterm babies. Adequate ventilation in the neonatal period presents particularly challenging characteristics, such as lung tissue immaturity, differences in the regional distribution of ventilation and susceptibility to injury induced by ventilation, which contribute to the high incidence of respiratory morbidity in patients ventilated during this period. Adequate neonatal ventilation reduces the course of bronchopulmonary dysplasia by reducing volutrauma and atelectrauma. No technology currently available for neonates assesses regional differences in ventilation or dynamic pulmonary changes. Clinical worsening is a late parameter of the ventilatory strategy and may represent potentially irreversible lesions of the pulmonary parenchyma. In this sense, the Electrical Impedance Tomography (EIT) for neonates is a valuable tool as a noninvasive method of continuous monitoring of ventilation, allowing better individualization and therapeutic appropriateness for each patient, besides helping to determine the degree of lung disease. Timpel has already developed and markets an Electric Impedance Tomography model for adult and pediatric use. To achieve the project goal six challenges must be overcome in this project: 1) Incorporation image reconstruction algorithm; 2) Industrial development of a patient cable to facilitate handling in the incubator; 3) Industrial development of a soft and adherent electrode strap, adequate to the level of cutaneous fragility of neonates; 4) Clinical studies and publications, with generation of case reports, safety evidence, standard of normality and suggested clinical conducts; 5) Brazilian (ANVISA) and European (CE mark) Certifications; 6) Launch in the European Society of Intensive Care Congress. (AU)