Directed Systems has received a COVID-19 Continuity Grant from Innovate UK to ensure the continuity and completion of its project so its clinical decision support technology, Hypotension Decision Assist (HDA) can be brought to operating theatres in hospitals as soon as possible.
HDA, is a clinical decision support Software as a Medical Device (SaMD) that is installed on a medically-rated touch-screen computer that supports anaesthetists. It provides intuitive visualisation on a single display of critical information about emerging critical cardiovascular situations to help better manage hypotension during surgery in the operating theatre.
Appropriate interventions can be used by anaesthetists to keep patients stable and avoid inter-operative hypotension (IOH). IOH can cause poor outcomes, even death – especially in high-risk patients undergoing surgery. Even short periods of IOH during surgery, where it falls below certain patient specific critical thresholds, may increase the risks of organ injury and other adverse outcomes for the patient. A 2014 study of almost 17,000 anaesthetic records revealed that 26% of the surgical patients involved had a peri-operative systolic blood pressure of < 80 mmHg for > 5 minutes. The threshold for myocardial injury is an operative Mean Arterial Pressure (MAP) < 65mmHg. The threshold for renal injury may be higher, possibly nearer 75 mmHg. A few minutes of a MAP < 55mmHg is associated with Acute Kidney Injury and Myocardial Injury and has been demonstrated to increase markedly with prolonged intra-operative hypotension.
HDA is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least 18-years-old that are undergoing surgery where their invasive arterial pressure is being continuously monitored by a multi-parameter operating room patient monitor. It is indicated for use to assist anaesthesia healthcare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery. The U.S. Food and Drug Administration (FDA) 510(k) clearance of a US version of HDA was received in November 2019. Preparations for a US launch are underway.