RecruitingOBSERVATIONAL

Non-invasive Blood Pressure Monitoring in Carotid Surgery

This study is exploring a new, less invasive way to monitor blood pressure during a common neck artery surgery called carotid endarterectomy. Currently, doctors insert a small tube into an artery for continuous blood pressure checks, which can be uncomfortable and has small risks. This research investigates whether a new device, a digital cuff that fits on the finger, can accurately measure blood pressure continuously without needing an arterial tube. The main goal is to compare how well these two methods — the traditional invasive one and the new finger cuff — match up. This is an observational study, meaning patients receive their usual care, and the new device is simply added alongside. The hope is to find a more patient-friendly way to keep a close eye on blood pressure during this important surgery.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

01 May 2026

Estimated completion

01 May 2026

Carotid Endarterectomy Surgery

What is this study about?

When you have surgery on a main artery in your neck, called a carotid endarterectomy, it's really important for doctors to continuously monitor your blood pressure. This constant monitoring helps them make sure your brain and heart are getting enough blood and to catch any problems early. Usually, this is done by carefully inserting a small tube, called an arterial catheter, into an artery right at the beginning of the operation. While very effective, some patients find this procedure uncomfortable, and there's a very small chance of issues like infection or problems with blood flow where the tube is inserted.

This study is looking at an exciting new way to measure blood pressure continuously during this surgery without needing to insert a tube. It uses a special digital cuff, similar to a pulse oximeter you might wear on your finger, that measures your blood pressure by detecting your pulse waves. The big question for researchers is how accurately this new cuff measures blood pressure compared to the traditional arterial tube method. They want to make sure it's just as reliable so that doctors can still make the best decisions during your surgery.

This is an observational study, which means that patients having carotid endarterectomy will receive their standard care exactly as planned, including the usual arterial catheter. The new digital cuff will simply be added alongside to collect extra information. Researchers will then compare the readings from both methods. This study aims to help us understand if this less invasive, more comfortable method could eventually be a good alternative for monitoring blood pressure during this important surgery.

Key takeaways

This study evaluates a gentle, needle-free way to check blood pressure during neck artery surgery.
It compares a new digital finger cuff to the traditional method that uses a small tube in an artery.
The aim is to find out if the new cuff is just as accurate and reliable.
Patients get their usual care; the new device is simply added for observation.
Participation doesn't involve extra procedures or changes to your surgery plans.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over, who is scheduled to have carotid endarterectomy surgery under general anaesthetic. You also need to have been fully informed about the study and agree to take part, or at least not object to your anonymous data being used.

There are a few reasons why someone might not be able to join. For example, if it's not possible for doctors to safely insert the traditional arterial tube or the new digital cuff because of a physical reason. Also, if you’re an adult but can’t make your own decisions about your healthcare, or if you are under guardianship, curatorship, or are in prison, you unfortunately wouldn't be able to participate.

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 18 years old or older?
Are you scheduled for carotid endarterectomy surgery?
Will you be having general anaesthetic for your surgery?
Are you an adult able to understand and make decisions about your healthcare?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't have any extra appointments or receive any new medications. You will have your carotid endarterectomy surgery as planned. As part of your standard care, an arterial catheter will be inserted for blood pressure monitoring. The only difference is that a new non-invasive device, a digital cuff, will also be placed on your finger, on the same side of your body as the arterial catheter. This cuff will simply collect additional blood pressure data during your surgery. There are no follow-up visits specifically for the study. The total duration of your participation is just during the surgery itself.

Potential risks and benefits

There are no known direct benefits to you for participating in this specific study, as the goal is to gather information for future patient care. There are also no additional risks beyond those normally associated with your carotid endarterectomy surgery and the standard arterial catheter insertion. The non-invasive digital cuff is generally safe and doesn't involve any needles or discomfort. Your participation is completely voluntary, and you are free to withdraw at any time without it affecting your medical care.

Locations (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE
Verified postcode
Créteil, France· Recruiting

Common questions

What is carotid endarterectomy surgery?

It's an operation to clear blockages in the main arteries in your neck that supply blood to your brain, helping to prevent strokes.

Why is blood pressure monitoring so important during this surgery?

Keeping a close eye on blood pressure helps doctors ensure your brain and heart are getting enough blood throughout the operation, which is vital for your safety.

What's the difference between the traditional and new ways of monitoring?

The traditional way involves a small tube (catheter) inserted into an artery. The new way uses a soft cuff on your finger, similar to a pulse oximeter, so no needles are needed for the monitoring itself.

Will my surgery change if I join this study?

No, your surgery and care will be exactly the same as planned. The new digital cuff will just be used alongside the standard monitoring to gather extra information.

Do I have to take part?

No, taking part is completely your choice. Your decision won't affect the care you receive for your surgery.

How to find out more

Nicolas Bertrand, MD

nicolas.bertrand@aphp.fr (+33) 0149835907 Official trial record

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