Active — Not RecruitingNot Applicable

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

United Kingdom20 participantsStarted 2025-02-14

Plain-language summary

The main goal of this study is to see how well a non-invasive lactate sensor measures lactate levels compared to standard blood tests. This might reduce the need for frequent blood draws during surgery recovery, and also provide a more comfortable experience for patients. This will also give us information regarding the suitability of the lactate sensor for monitoring other patients - for instance people attending the accident and emergency department with chest pain in which lactate levels may help make a quick diagnosis. Patients will be approached for this study if they are undergoing routine coronary artery bypass surgery (CABG) or valve replacement surgery. Participants will wear the non-invasive lactate sensor for up to 14 hours, and the readings will be correlated to lactate levels in blood samples. Once the sensor has been removed and the participant has been discharged from their elective surgery admission, the participant has completed the study. Participation in this study and the data collected from the sensor will help us understand how well it works and how it can be used to improve patient care in the future. In the future, the data from this new device will be used to train computer algorithms to provide quick responses that could help manage a patients condition, improving future medical care.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \&lt;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 (\&lt;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 (\&lt;35 g/L recorded within 6 months of consent date) * Those lacking capacity to consent or are…

What they're measuring

Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements.

Timeframe: 14 hours

Continuous lactate sensor measurement compared Troponin-T

Timeframe: 14 hours

Trial details

NCT IDNCT06597253

SponsorQueen Mary University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-25