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Feasibility and Outcomes of Endovascular Aneurysm Repairs (EVARs) Without Arterial Line Monitoring

This study is exploring a new way to perform a procedure called Endovascular Aneurysm Repair (EVAR). EVAR is a common, less invasive surgery to fix a weakened and bulging main artery in the tummy, known as an abdominal aortic aneurysm. Usually, doctors use a special tube (an arterial line) to constantly check blood pressure during this surgery. However, our hospital has found that for some patients, this monitor might not always be needed. This study will compare patients undergoing EVAR with or without an arterial line. We'll look at their health before, during, and after the operation, and also how staff feel about the new approach. The goal is to make the EVAR procedure even safer and more comfortable for patients.

At a glance

Status
Not yet recruiting
Sponsor
Nova Scotia Health Authority
Enrolment target
100
Start
01 Aug 2024
Estimated completion
01 Dec 2025

What is this study about?

When the main artery in your tummy (the aorta) becomes weak and bulges, it's called an abdominal aortic aneurysm. If it gets too big, it can be serious. Doctors often fix this with a procedure called an Endovascular Aneurysm Repair, or EVAR. This is a less invasive way to treat the condition, meaning it doesn't involve a large cut like older operations. Instead, doctors use small tubes inserted into your groin to place a special stent inside the artery, making it strong again.

Traditionally, during an EVAR, a special thin tube called an arterial line is put into an artery in your arm or wrist. This line allows doctors to get a very accurate, moment-by-moment reading of your blood pressure and also to take blood samples easily. It's a standard safety measure. However, some doctors believe that in certain straightforward cases, this arterial line might not always be necessary, potentially making the procedure simpler and more comfortable for patients.

This study wants to find out if it is truly safe and effective to perform EVARs without routinely using an arterial line for all patients. We will compare patients who have the arterial line with those who don't. We'll be looking closely at how they recover, if there are any problems, how long the operation takes, and what the nurses and doctors think about the experience. The aim is to make the EVAR procedure even better, safer, and potentially more comfortable for patients in the future.

Key takeaways

  • The study explores whether EVARs can be safely done without continuous blood pressure monitoring.
  • It aims to improve patient comfort and simplify the EVAR procedure.
  • Participation involves routine medical care, with data collected from your health records.
  • Your doctors will always make decisions based on your safety and best care.
  • The study is happening at Queen Elizabeth II Health Sciences center.

Who may be eligible?

This study is looking for adult patients who are having an EVAR procedure at the Queen Elizabeth II Health Sciences center between June 1st, 2024, and May 31st, 2025. You would need to be having a specific type of EVAR where the approach is generally less complicated and doesn't require complex techniques or a big cut to access the blood vessels in your leg.

You wouldn't be able to join this study if your EVAR requires a different, more complex type of stent, or if certain specific medical conditions or features of your blood vessels make it riskier to go without an arterial line. For example, if your arteries are very hardened, if you have a certain type of severe heart condition, or if your blood pressure is very high on the day of surgery, you likely wouldn't be eligible. Also, if your surgeon or anaesthetist feels it's better for your safety to have an arterial line, you wouldn't be included in this particular 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.

  1. Are you an adult patient?
  2. Are you having a standard EVAR procedure at Queen Elizabeth II Health Sciences center?
  3. Do you have a straightforward aneurysm that doesn't need very complex treatment?
  4. Do your doctors agree that you fit the study criteria for safety?
Answer every question to see your result.

What does participation involve?

If you decide to take part, what happens during your EVAR procedure will be decided by your doctors, and some patients in the study will have an arterial line while others won't. You won't have any extra visits to the hospital or different medications as part of this study. The study will mainly involve collecting information from your routine medical records before, during, and after your EVAR operation. This will include details about your health before the surgery, how the operation went, and how you recovered. Some operating room staff might also be asked to fill out a short survey about their experience.

Potential risks and benefits

The potential benefit of this study is that it could help improve the EVAR procedure, potentially making it simpler and more comfortable for patients in the future. There are no extra risks for you from taking part, as the care you receive will be based on what your doctors believe is best for your safety. Regardless of whether you join, your doctors will always prioritise your health and well-being. Remember, you can choose not to participate in the study or withdraw at any time without affecting your medical care.

Locations (1)

  • QEII Health Sciences Center
    Verified postcode
    Halifax, Canada

Common questions

What is an abdominal aortic aneurysm?

It's a weak, bulging spot in the main blood vessel that runs from your heart through your tummy.

What is an EVAR?

It's a less invasive operation to fix an abdominal aortic aneurysm using a special tube and stent graft.

What is an 'arterial line'?

It's a small tube usually put into an artery (like in your wrist) to constantly check your blood pressure during surgery.

Will I know if I'm getting an arterial line?

Your medical team will discuss your care with you, including whether an arterial line is part of your planned procedure.

How long does the study last for me?

Your participation involves using information from your medical records from your EVAR operation and recovery, so it doesn't extend your hospital stay or follow-up.

How to find out more

Loukman Ghouti

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

Interested in taking part?

Register your interest

Share your details and the research team for "Feasibility and Outcomes of Endovascular Aneurysm Repairs (E…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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