Development and insertion in the market of Electrical Impedance Tomography equipment for the treatment of patients on artificial ventilation due to respiratory failure caused by COVID

  • Funded by Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Total publications:0 publications

Grant number: 2020/04797-4

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2021
  • Funder

    Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Principle Investigator

    Pending
  • Research Location

    Brazil, Americas
  • Lead Research Institution

    Timpel
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Supportive care, processes of care and management

  • Special Interest Tags

    Gender

  • Study Subject

    Non-Clinical

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Not Applicable

  • Vulnerable Population

    Not applicable

  • Occupations of Interest

    Not applicable

Abstract

The project aims to develop and place on the market an Electrical Impedance Tomography (TIE) equipment for the treatment of patients on artificial ventilation due to respiratory failure caused by COVID (TIE-COVID). Electric 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. While 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 preservation 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, 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 spread the use and increase access to more individualized and effective ventilatory treatment, including for emergency departments in hospitals, this project aims at the development and emergency insertion in the market of an Electric Impedance Tomography (TIE) equipment dedicated for the treatment of patients under artificial ventilation due to respiratory failure caused by COVID (TIE-COVID). The project involves: 1. Development of an algorithm and specific functionality for adjusting the 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 sterilizing 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 market insertion; 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.