Study of Non-invasive Hypotension Prediction Index Monitoring to Reduce Low Blood Pressure During Major Trauma and Orthopedic Surgery

What this Trial Is About

Researchers are evaluating whether using a continuous non-invasive cardiac output monitoring system called ClearSight, guided by the Hypotension Prediction Index HPI, can reduce episodes of low blood pressure during surgery intraoperative hypotension or IOH. This study focuses on patients aged 45 and older undergoing major trauma or orthopedic surgeries. The goal is to see if this monitoring method can also lower the risk of postoperative acute kidney injury AKI and myocardial injury after non-cardiac surgery MINS. Participants will be randomly assigned to one of two groups one group will receive goal-directed therapy GDT guided by the ClearSight system using the HPI to predict and prevent hypotension, while the other group will receive standard care with routine non-invasive blood pressure monitoring every three minutes. The intervention period lasts from the start to the end of surgery, with individualized optimization of cardiac index and contractility in the intervention group. Both groups will receive standard anesthesia and monitoring protocols. Throughout the study, patients will be assessed before surgery and at multiple times after surgery immediately, 24, 72, and 168 hours. Researchers will collect clinical data, blood, and urine samples to monitor kidney and heart function, inflammation, and endothelial health. The primary outcomes measured are the frequency and duration of intraoperative hypotension. Secondary outcomes include rates of AKI and MINS. Data will be collected and analyzed securely, with patient consent and privacy protections in place.

Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension