A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery andor Valve Replacement

What this Trial Is About

Researchers are evaluating a wearable device designed to continuously monitor lactate levels in the body for patients undergoing planned coronary artery bypass graft CABG andor valve replacement surgery. The goal is to compare the devices readings with standard blood tests to verify accuracy. If successful, this device could reduce the need for frequent blood tests during surgery recovery and may also help in emergency rooms, especially for patients with chest pain. The study is conducted at Barts Hospital and sponsored by Queen Mary University of London. Participants will have two lactate sensors placed on their upper arm up to five days before surgery, with a 24-hour warm-up period before continuous measurement begins. During and after surgery, the sensors will monitor lactate levels for up to 48 hours. Hourly blood samples will be taken for up to 14 hours during surgery to compare with the sensor readings, including measurements of arterial and venous lactate, as well as venous troponin. Vital signs such as blood pressure, heart rate, and respiratory rate will be monitored regularly, and any medication changes will be recorded. Participants will undergo assessments including ECGs, blood pressure, heart rate, respiratory rate, and blood tests both before and after surgery. The sensors will be removed within 48 hours post-surgery, and the skin will be checked for any reactions. Follow-up monitoring will continue for up to 24 hours after sensor removal or until hospital discharge. Researchers will evaluate the devices accuracy, functionality, and safety through continuous lactate sensor measurements compared to standard blood tests over 14 to 48 hours, and safety monitoring up to 8 days.

A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.