A Single-centre Study Comparing a Non-invasive Lactate Sensor to Standard Invasive Measurements in Patients Undergoing Coronary Artery Bypass Surgery.

Launched by QUEEN MARY UNIVERSITY OF LONDON · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of non-invasive lactate sensor that measures lactate levels in patients undergoing coronary artery bypass surgery or valve replacement. Lactate is a substance in the blood that can indicate how well your body is managing during and after surgery. The goal is to see if this new sensor can provide accurate readings without needing frequent blood draws, which can make recovery more comfortable for patients. If successful, this device could also be useful in other medical situations, like quickly assessing patients with chest pain in emergency departments.

To participate in this study, you need to be between 18 and 90 years old and able to give informed consent. You should also be scheduled for a routine surgery and not have certain health conditions, such as severe heart failure or recent serious heart problems. If you volunteer, you will wear the sensor for up to 14 hours after your surgery, and your lactate levels will be compared to regular blood test results. This research aims to improve patient care by understanding how well this sensor works and potentially using the information to develop quicker medical responses in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able and willing to give informed consent
• • ≥18 to ≤ 90 years old
• * Successful surgery as defined by the below criteria (which will be recorded in the eCRF):
• • Operative Success: The successful completion of coronary artery bypass grafting (CABG) +/- valve insertion with grafts and/or valves
• * Absence of the following complications:
• • Significant bleeding requiring reoperation
• • Evidence of major life-changing stroke
• Exclusion Criteria:
• • Previous coronary artery bypass grafting
• • Recent acute coronary syndrome (within 4 weeks of consent date)
• • Heart failure with EF \<35% (from TTE or CT from past 6 months - if both available lower value will be used).
• • Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula recorded within 6 months of planned consent date)
• • Severe anaemia (\<10 recorded within 6 months of planned consent date)
• • Known or suspected allergies to medical grade silicone adhesives
• • Pre-existing skin condition on the upper arm where the device would be applied, including recent burns/ scalds, open wounds or clinically significant skin lesions.
• • Patients with implanted medical devices such as pacemakers or other CLMs
• • Severe liver cirrhosis (≥ stage III)
• • Lymphoedema or pitting oedema at the time of consent
• • Pregnancy
• • History of ongoing malignant disease
• • Hypoalbuminaemia (\<35 g/L recorded within 6 months of consent date)
• • Those lacking capacity to consent or are deemed vulnerable adults
• • Unable to speak English