RecruitingOBSERVATIONAL

Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery

This international study is exploring how carefully managing blood pressure during and after heart surgery might help protect the brain. We know that some people experience problems like confusion (delirium), memory issues, or even a stroke after heart operations. This research will use special monitors during surgery to check how well blood flows to each patient's brain and how their body regulates blood pressure individually. The goal is to see if keeping blood pressure within a person's ideal range can reduce these brain-related complications. By understanding how individual blood pressure targets affect brain health, doctors hope to improve safety and recovery for patients undergoing heart surgery in the future.

At a glance

Status

Recruiting

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

500

Start

23 Jan 2023

Estimated completion

01 Aug 2027

Postoperative Delirium Postoperative Stroke Postoperative Cognitive Dysfunction

What is this study about?

Heart surgery is a major operation, and while it helps many people, some patients can experience problems like confusion, memory difficulties, or even a stroke afterwards. These are called 'neurological events' and can affect how well someone recovers and their quality of life. At the moment, we don't fully understand why these problems happen or how best to prevent them.

This important international study aims to find out if managing blood pressure very carefully and personally during and after heart surgery can help reduce these brain-related problems. Doctors will use special equipment, like monitors that shine light into your head (NIRS) and ultrasound to look at blood flow in your brain (TCD). This helps them understand each person's unique 'cerebral autoregulation' – which is how your brain keeps its blood supply steady, even if your body's blood pressure changes.

The main idea is to see if patients whose blood pressure goes outside their brain's ideal range for too long or by too much are more likely to develop confusion, memory problems, or a stroke after surgery. The study will also look at certain markers in the blood and genetic information to get a deeper understanding of what causes these issues. Ultimately, this research hopes to lead to more personalised and safer ways to manage patients during heart surgery, improving their recovery and overall well-being.

Key takeaways

Aims to understand blood pressure's effect on brain health during heart surgery.
Uses special monitors to check brain blood flow (NIRS, TCD).
Hopes to reduce confusion, memory issues, and stroke after surgery.
Does not involve new medications, mainly extra monitoring.
Findings could lead to safer, more personalised heart surgery care.
Open to patients aged 65+ undergoing specific planned heart operations.

Who may be eligible?

This study is looking for adults aged 65 or older who are having specific types of heart surgery. This includes operations to bypass blocked arteries (coronary artery bypass graft), fix heart valves, or surgery on the main large artery leaving the heart (ascending aorta), as long as it involves a heart-lung machine.

There are certain situations where you wouldn't be able to join. For example, if your surgery requires very deep cooling, or if you're having a heart or lung transplant. Also, people needing urgent or emergency surgery (within 24 hours), or those who can't understand the study procedures because of language barriers or other reasons, wouldn't be eligible.

If you're having heart surgery where a special, smaller heart-lung machine (minimal extracorporeal circulation) is used, you also won't be able to take part in this specific study.

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.

Am I aged 65 or older?
Am I having planned heart surgery (not emergency)?
Is my surgery for bypass, a valve, or ascending aorta?
Will my surgery definitely involve a heart-lung machine?
Will my surgery *not* involve deep body cooling?
Can I understand information in English, German, or French?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, the main activities would involve collecting information before, during, and after your heart surgery. Before your operation, some of your existing health details will be gathered. During surgery, special non-invasive monitors will be used to measure blood flow and oxygen levels in your brain. These might include small sensors placed on your forehead (NIRS) and an ultrasound device used near your temples (TCD).

After your surgery, similar brain monitoring might continue for a period. You would also have blood samples taken to look for specific markers related to brain health and, with your consent, for genetic studies. The study primarily involves adding monitoring and data collection to your planned surgery and recovery; it does not involve taking new medications specifically for the study. The total duration of your participation would cover your hospital stay and any follow-up appointments where data is collected, but it's not specified how long this might be.

Potential risks and benefits

Taking part in this study involves using additional monitoring equipment during and after your surgery. While these monitors are generally considered safe and non-invasive, there's always a very small chance of minor skin irritation. The main benefit may not be directly for you, but for future patients, as this research aims to improve understanding and care during heart surgery. You always have the right to change your mind and withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
Verified postcode
Basel, Switzerland· Recruiting
Inselspital, Bern University Hospital
Verified postcode
Bern, Switzerland· Recruiting
Cambridge University Hospitals and Brain Physics Lab
Verified postcode
Cambridge, United Kingdom· Active not recruiting
Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is 'postoperative delirium'?

It's a state of sudden confusion that can happen after surgery, where you might feel disoriented or have trouble concentrating.

What does 'cerebral autoregulation' mean?

It's your brain's natural ability to keep its blood flow steady, even if your body's overall blood pressure changes.

Will I have to take any new medicines for this study?

No, this study mainly involves extra monitoring and data collection, not taking new medications.

How will my blood pressure be monitored?

Doctors will use standard invasive blood pressure monitoring, along with special non-invasive brain monitors like NIRS and TCD.

Will my genetic information be shared?

Genetic studies will only be done if you give specific written consent, and all data will be kept confidential.

How to find out more

Nuno V. Gomes, MD

nuno.gomes@usb.ch +41 61 328 64 46 Official trial record

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