Demonstration and validation of a chest patch capable of monitor children’s vital signs in real time using Artificial Intelligence

Summary


The readmission of patients to pediatric intensive care units (PICU) after discharge, although a rare event, is a matter of major concern for intensive care physicians because it is associated with a sharp increase in morbidity and mortality. The rate of unscheduled readmission to the PICU ranges from 2.5 to 8% and up to 40% of these readmissions occur within 48 hours of discharge from the PICU. The main problem is that the monitoring of these patients is drastically changed once they leave the PICU and reliable alert systems are not available. In this context, artificial intelligence and remote monitoring, could be of great help in detecting patients at risk at an early stage. Connected objects such as smartwatches and patches have been used more and more in health research for more than 5 years now. In adult patients, studies have shown that these devices are well tolerated and may be a reliable way to monitor patients’ vital signs. These devices are now marketed, though very limited, in adults but they do not exist for children. To manufacture a medical device as such would be unique and would meet a real clinical need. Given the variability in the size of children’s wrists and their significant need to move their hands which can create artifacts, patch may be a better monitoring device in this age group. We have already developed a patch for children and we are waiting for the investigational testing authorization (ITA) to run a clinical trial at the Ste-Justine hospital at NICU level. This will help us to prepare the requirements to get the 510K standard from Health Canada to serve as a medical device. When we are approved as a medical device, we could start selling to children’s hospitals as a B2B approach.

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