Development and commercial launch of electrical impedance tomography equipment for the treatment of patients on artificial ventilation due to respiratory failure caused by COVID

• Grant number: 20/04797-4
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: May 01, 2020
• End date: June 30, 2021
• Field of knowledge: Engineering - Biomedical Engineering - Bioengineering
• Agreement: FINEP - PIPE/PAPPE Grant
• Principal Investigator: Rafael Holzhacker
• Grantee: Rafael Holzhacker
• Company: Timpel S/A
• CNAE: Fabricação de equipamentos e aparelhos elétricos não especificados anteriormente ; Atividades profissionais, científicas e técnicas não especificadas anteriormente
• City: São Paulo
• Associated researchers: Luiz Henrique de Moura Teixeira Balloti ; Taciana Tonetto Castelo Branco Trigo
• Associated research grant(s): 20/06640-5 - Development and commercial launch of electrical impedance tomography equipment for the treatment of patients on artificial ventilation due to respiratory failure caused by COVID, AP.PIPE

Abstract

The project aims to develop and commercial lunch of an Electrical Impedance Tomography (TIE) equipment for the treatment of patients on artificial ventilation due to respiratory failure caused by COVID (TIE-COVID). Electrical Impedance Tomography is a non-invasive, radiation-free medical equipment used at the bedside, which allows the real-time assessment of regional ventilation distribution, and the identification of phenomena such as asynchrony, pneumothorax, collapse and pulmonary hyperdistention. One of the main problems associated with COVID-19 is the overload of the health system, especially the ICUs, due to the need for ventilatory support for the most critical cases of the disease. At the same time that researchers evaluate the use of anti-viral drugs, it is necessary to optimize the ventilatory treatment of the patient, to reduce the length of hospital stay and alleviate the burden imposed on the health system. From the experience of American, Italian and Spanish doctors, we have identified that the handling of the ventilator that COVID-19 requires has often proved to be anti-intuitive. If you only follow the standard protocols for handling the artificial ventilator (such as the ARDSNet table), the treatment, in addition to being ineffective, can cause even greater damage and require longer hospital stays and availability of ventilators. Recent studies indicate that patients with COVID-19 have hypoxemia disproportionate to the radiological and mechanical impairment of the lung; unlike swine flu, respiratory mechanics are good in the early stages of the disease, with lung compliance very well preserved. And here there is a paradox: as the hypoxemia is profound, due to a major failure of hypoxic vasoconstriction, the doctor ends up "flushing" and using much higher pressure (PEEP), resulting in hemodynamic impairment and organ failure, leading to a vicious circle that often results in increased length of hospital stay and death. Thus, it is necessary to adjust ventilation individually, minimizing adverse events caused by ventilation itself, and addressing respiratory failure in a targeted manner. The reduction in complications and the consequent reduction in ventilation time will result in greater availability of ICU beds. To disseminate the use and increase access to a more individualized and effective ventilatory treatment, including for emergency sectors of hospitals, this project aims to develop and insert an Impedance Electrical Tomography (TIE) equipment in the market for the treatment of patients on artificial ventilation due to respiratory failure caused by COVID (TIE-COVID). The project involves: 1. Development of an algorithm and specific functionality for adjusting PEEP and treating patients with COVID, to optimize ventilation, so that the patient is released from the ventilator as soon as possible; 2. 40% price reduction in relation to current Timpel equipment, with size reduction, battery inclusion, making the equipment accessible to all ICUs in Brazil; 3. Development of a disposable electrode belt, given the care that must be taken in relation to contamination by coronavirus, cleaning and sterilization of the equipment; 4. Development of remote access to equipment, to allow access to information outside the contaminated environment; 5. Prototyping, verification, validation; 6. ANVISA certification and insertion in the market; Gross revenue from the project is estimated at R $ 8.6 million as of the first year after launch, reaching R $ 12.5 million in the fifth year. (AU)