RecruitingOBSERVATIONAL

Comparison of Cardiac Index and Stroke-volume-index Measured by Pulmonary Artery Catheter, FloTrac® and Argos® in Cardiac Surgery Patients.

This study looks at three different ways to measure how effectively your heart is pumping blood around your body, specifically focusing on a measurement called 'cardiac index' and 'stroke volume index'. These measurements tell doctors if your heart is doing its job well. The three methods being compared are the Pulmonary Artery Catheter, FloTrac, and Argos Monitor. Researchers will take these measurements in patients during and after heart surgery, both in the operating theatre and in the intensive care unit. This research is important because it helps doctors understand which monitoring tools give the most accurate and helpful information, ultimately improving care for patients undergoing heart operations.

At a glance

Status

Recruiting

Sponsor

Karlsburg Hospital

Enrolment target

Start

01 Mar 2025

Estimated completion

01 Dec 2025

Cardiac Failure Acute Hemodynamic Monitoring

What is this study about?

When you have heart surgery, it's really important for doctors to know if your heart is pumping blood effectively. This study is like a comparison test for three different tools that measure how well your heart is working. Think of it like comparing three different thermometers to see which one gives the most accurate reading of your temperature. Here, instead of temperature, they're looking at how much blood your heart is pumping with each beat and each minute.

The three tools being compared are called the Pulmonary Artery Catheter, FloTrac, and Argos Monitor. Doctors will use these tools to take measurements in people who are having, or have just had, heart surgery. They'll do these checks both when you're in the operating room and afterwards when you're recovering in the intensive care unit (ICU).

The main goal of this study is to find out which of these tools gives the most reliable and useful information for doctors. Having accurate information helps doctors make the best decisions about your care after heart surgery, making sure your heart recovers well. It's all about improving the monitoring and safety for patients like you.

Key takeaways

Compares three heart monitoring tools.
For patients having heart surgery.
Aims to find the most accurate heart performance measurements.
Could lead to better care for future heart surgery patients.
Participation involves monitoring during and after surgery.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you must have recently had heart surgery. This study is specifically for patients who already have a special tube, called a pulmonary artery catheter, placed in their heart as part of their standard care after surgery.

There are a few reasons why you might not be able to join. If your heart and blood pressure are very unstable, meaning they are changing rapidly and unpredictably, you wouldn't be able to participate. Also, you need to be able to understand and agree to take part in the study yourself, so if you are unable to give your consent, you wouldn't be eligible.

This study is open to both men and women, and to adults of all ages, from 18 years old upwards. So, if you're an adult and meet the requirements above, you might be able to take part.

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.

Are you an adult (18 years or older)?
Have you recently had heart surgery?
Do you already have a pulmonary artery catheter in place?
Is your medical condition currently stable (not rapidly changing)?
Can you understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing that will happen is that doctors will use the three different monitoring tools (Pulmonary Artery Catheter, FloTrac, and Argos Monitor) to measure your heart's performance. These measurements will mainly be taken while you are already in the operating theatre for your heart surgery and afterwards when you are in the intensive care unit (ICU).

Since you would already have a pulmonary artery catheter as part of your standard medical care, and the other monitors are usually put on your body or connected to existing lines, there won't be many extra procedures specifically for the study. The doctors will simply be collecting and comparing the readings from these different devices during your recovery period. The overall duration of your participation would be limited to the time you are being monitored in the operating room and ICU after your heart surgery, usually a few days at most.

Potential risks and benefits

Participating in this study might not offer direct personal health benefits to you, as its main aim is to improve care for future patients. However, by taking part, you would be contributing to valuable medical knowledge that could lead to better monitoring and treatment for people undergoing heart surgery in the future. The risks of participating are expected to be very low, as the study uses monitoring equipment that would often be used in a hospital setting for similar patients, and much of the data is collected from existing procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Klinik für Anästhesiologie und Intensivmedizin, Klinikum Karlsburg
Verified postcode
Karlsburg, Germany· Recruiting

Common questions

What is 'cardiac index'?

It's a measurement that tells doctors how much blood your heart is pumping relative to your body size, giving an idea of how well your heart is working.

Will I have extra needles or procedures?

The study aims to use equipment you might already have or that is easily added, so extra invasive procedures specifically for the study should be minimal.

How long will I be in the study?

Your involvement typically lasts for the period you are being monitored in the operating room and ICU after your heart surgery.

Will my regular medical care change?

No, your standard medical care and treatment for your heart condition will continue as planned and won't be affected by your participation in this study.

Who is paying for this study?

The study details don't specify the funding source. This is a good question to ask the research team.

How to find out more

Matthias Heringlake

heringlake@t-online.de Deutschland Official trial record

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