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Clinical development of electrical impedance tomography by demonstrating its effectiveness and benefits in the treatment of patients with severe respiratory Dystress syndrome (SRDS)

Grant number: 15/22643-6
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: November 01, 2016 - October 31, 2019
Field of knowledge:Engineering - Biomedical Engineering - Medical Engineering
Principal Investigator:Maria Aparecida Miyuki Nakamura
Grantee:Maria Aparecida Miyuki Nakamura
Company:Timpel S/A
City: São Paulo
Co-Principal Investigators:Camila Cestaro de Almeida

Abstract

This project aims the clinical development of the Electrical Impedance Tomography (EIT), proving its effectiveness in the application of safer clinical procedures in critically ill patients. We aim to develop the arguments for market the TIE, justifying its reimbursement by payers and demonstrating the possibility of reducing hospital costs, morbidity and mortality of these patients. In this regard, a clinical decision support tool focused in protective ventilation will be developed, and will involve the development of a hemodynamic depression index as well as a recruitability index Timpel developed the EIT, an innovative medical device, non-invasive, radiation-free, which generates images quantifying the regional pulmonary ventilation during artificial ventilation. Getting information inaccessible to other technologies, the equipment allows to estimate the amount of collapsed / hiperdistended alveoli, according to the pressures set on the ventilator. It also allows continuous monitoring of cardiac output, as well as the quick detection of serious complications such as pneumothorax. Timpel obtained approval by ANVISA and the European Community in 2014.There are now doubts about the advantages / disadvantages of two mechanical ventilation paradigms of critical patients, respectively coined the ARDSnet and OLA. In order to prove the clinical utility of EIT, Timpel will participate in a large multicenter randomized trial entitled "Alveolar Recruitment for ARDS Trial (ART)" led by the Hospital do Coração-SP, aiming to include more than 1,000 patients. The main objective of the study is to compare the ART mortality with ARDSNet strategy (prioritizing the control of alveolar distention) compared to "OLA" strategy (prioritizing the alveolar recruitment). Preliminary studies indicate that the latter form of ventilation would reduce length of stay and hospital mortality. The hypothesis is that EIT would be beneficial to a better and more safe clinical application both strategies tested by ART, since: 1. The EIT would be able to detect most instances of pneumothorax, going in both strategies expected prevalence of 10%. In preliminary studies, EIT demonstrated sensitivity 10 times higher than the X-ray. 2. The EIT would be able to monitor the drop in cardiac output associated with alveolar recruitment maneuvers, allowing the detection of a drop of systolic volume earlier than by invasive blood pressure method. 3 - In patients randomized to OLA group, the EIT would objectively quantify the effectiveness of alveolar recruitment, allowing identify patients most benefited by the strategy (patients with lung more "recruitable"). 4 - Even in patients randomized to OLA group, the EIT would identify a value of PEEP different (or at least identified more accurately and objectively) that identified by the traditional method, recommended by the protocol. 5 - In patients randomized to the "ARDSnet" EIT identify those in which the reduction of inspiratory pressures cause a marked decrease in the "volume-functional" lung, causing "strain" excessive remaining parenchyma (a parameter also quantified by EIT). In summary, our hypothesis is that the EIT will allow early identification of serious pulmonary complications (pneumothorax) and heart (cardio-circulatory depression) in both trial arms, still allowing identify patients at increased risk of lung injury when subjected to each of the chosen strategies. The EIT would thus enable a more individualized strategy, avoiding the perverse strategy of "one size fits all". (AU)