All studies
Active not recruitingNAINTERVENTIONAL

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

This study looks at how well a new, non-invasive sensor measures lactate levels compared to traditional blood tests. Lactate levels can tell doctors a lot about a patient's health, especially during and after surgery. If successful, this new sensor could mean fewer blood tests for patients recovering from heart surgery, making their experience more comfortable. It could also help doctors in A&E quickly diagnose patients with chest pain. Participants will wear this sensor for a short time after their routine heart bypass or valve replacement surgery, and we'll compare its readings to regular blood test results. This research helps us understand how to use this new technology to improve patient care in the future.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Queen Mary University of London
Enrolment target
20
Start
14 Feb 2025
Estimated completion
25 Nov 2026

What is this study about?

Imagine being able to check important health levels without needing lots of needle pokes. That's what this study is exploring! We're looking at a new, comfortable sensor that gently sits on your arm to measure something called 'lactate'. Lactate levels can give doctors important clues about how well your body is coping, especially during and after major surgery like a heart bypass or valve replacement. Currently, we measure lactate using blood samples, which means regular needle sticks.

The main goal of this study is to see if this new sensor can measure lactate just as accurately as the traditional blood tests. If it can, it means patients might need fewer uncomfortable blood draws during their recovery, making their hospital stay a bit easier. This isn't just about heart surgery patients; if this sensor works well, it could potentially be used in other areas, like helping doctors in the Accident and Emergency department quickly check lactate levels for people coming in with chest pain, which could help make a fast diagnosis and lead to quicker treatment.

Ultimately, the information we gather from this study will help us understand how well this new technology works. It will also help us see how it could be used to make patient care better and more comfortable in the future, possibly even by training computer systems to use these readings to help doctors make even faster decisions.

Key takeaways

  • Exploring a new, comfortable sensor to measure lactate levels.
  • Aims to reduce the need for frequent blood tests after heart surgery.
  • Could help doctors diagnose conditions faster in the future.
  • Involves wearing a sensor for up to 14 hours after routine heart surgery.
  • Your participation helps improve future patient care.
  • Your treatment or recovery will not be affected.

Who may be eligible?

To join this study, you need to be having a routine heart bypass or heart valve replacement surgery at St Bartholomew's Hospital. You also need to be aged between 18 and 90, and be able to understand and agree to take part.

There are some reasons why you wouldn't be able to join. For example, if you've already had a heart bypass before, or if you've recently had a heart attack. Other reasons include certain serious kidney or liver problems, severe anaemia, or if you have a skin condition or an implanted device like a pacemaker that would interfere with the sensor placement. We also can't include pregnant women or anyone who is unable to understand the study information.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you having heart bypass or valve replacement surgery at St Bartholomew's Hospital?
  2. Are you between 18 and 90 years old?
  3. Are you able to understand and agree to take part in the study?
  4. Have you not had a recent heart attack (within the last 4 weeks)?
  5. Do you not have severe kidney or liver problems, or severe anaemia?
  6. Do you not have a skin condition on your upper arm where the sensor would be placed?
Answer every question to see your result.

What does participation involve?

If you decide to take part, a nurse or doctor will explain the study in detail and answer all your questions. We'll check your medical history, current medications, and do a quick health check like measuring your blood pressure and heart rate. You'll have your planned heart surgery as normal. After your surgery, when you're settled in the intensive care unit, a soft sensor will be placed on your arm. You might even be asleep when this happens. This sensor will stay on for up to 14 hours and will continuously measure your lactate levels. During this time, we will also take regular, hourly blood samples through the tubes already in place for your surgery, so we can compare these results with the sensor readings. Once the sensor is removed and you're discharged from your hospital stay for the surgery, your part in the study is complete.

Potential risks and benefits

Taking part in this study won't change your planned heart surgery or usual care. The sensor is non-invasive, meaning it won't break your skin, and is generally considered safe and comfortable. The main benefit is helping us learn more about this new technology, which could lead to more comfortable monitoring for patients in the future, with fewer needle pokes. There's a very small chance of skin irritation from the sensor's adhesive. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Barts Health
    Verified postcode
    London, United Kingdom

Common questions

What is lactate?

Lactate is a chemical your body makes, especially when it's under stress or not getting enough oxygen. Doctors check lactate levels to understand how well your body is functioning.

Will this study change my surgery or recovery?

No, your planned heart surgery and your recovery care will happen exactly as they would normally. This study adds a sensor and some extra blood tests, but it won't alter your main treatment.

Will the sensor hurt?

The sensor is soft and sticks to your arm like a patch. It doesn't break the skin, so it shouldn't be painful. Many patients might even be asleep when it's put on.

How long will I wear the sensor?

You'll wear the sensor for up to 14 hours after your surgery while you're in the intensive care unit.

What happens after the sensor is removed?

Once the sensor is removed, your part in the study is finished. You'll continue with your recovery and go home as planned for your surgery.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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