RecruitingNAINTERVENTIONAL

Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)

This study, called "SystoWean," is trying to understand why some patients struggle to breathe on their own after being on a breathing machine (mechanical ventilation). Specifically, it's looking at whether the heart's ability to pump blood effectively plays a role when fluid builds up in the lungs, a problem known as "weaning-induced pulmonary edema." This fluid build-up can make it very difficult for patients to come off the breathing machine, leading to longer stays in intensive care and potential health problems. Researchers want to use a special heart scan called an echocardiogram to see how well the left and right sides of the heart are working during the process of trying to get patients to breathe for themselves.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

250

Start

08 Aug 2022

Estimated completion

01 Sep 2026

Mechanical Ventilation Complication Pulmonary Edema

What is this study about?

When someone is very unwell, they might need a breathing machine to help them breathe. After a while, doctors try to gradually take them off this machine. This process is called 'weaning.' However, sometimes patients struggle with this, and it's called 'weaning failure.' One common reason for this struggle is something called 'weaning-induced pulmonary edema,' which simply means that fluid builds up in the lungs, making it very hard to breathe independently.

This study, named "SystoWean," is designed to investigate why this fluid build-up happens in some patients and not others. Researchers believe it might be linked to how well the heart is pumping blood. The heart has two main pumping chambers: the left ventricle and the right ventricle. When these don't work as effectively as they should, it could contribute to fluid collecting in the lungs.

The main goal of this study is to find out if the pumping ability of the heart is involved in causing this fluid build-up during weaning. They'll also be looking to see if there's a better way to measure the heart's pumping function using a special type of scan called an echocardiogram, which uses sound waves to create pictures of the heart. By understanding this better, doctors hope to improve how they help patients come off breathing machines and reduce the risks associated with longer stays in intensive care.

Key takeaways

This study investigates why some patients struggle to breathe after a ventilator.
It focuses on how well the heart's pumping chambers work during this time.
Researchers will use a heart scan (echocardiogram) to gather information.
The goal is to understand fluid build-up in the lungs (pulmonary edema).
Results could help improve care for patients coming off breathing machines.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) who has been on a breathing machine for more than two days. Your doctors would need to believe you are ready to try breathing on your own, meaning your oxygen levels are good, you can cough effectively, and you are generally stable.

Additionally, you would need to be considered at a higher risk of developing fluid in your lungs during the weaning process. This might be because you have a higher body mass index (are obese), have ongoing lung conditions like COPD, or have a history of heart problems.

You would not be able to join if you are pregnant, have a serious heart valve condition, have a pacemaker, have a tube in your neck for breathing (tracheostomy), or have certain long-term muscle or nerve conditions. Also, if the doctors have decided not to try to save your life (a 'do not resuscitate' order) or if the heart scans would be difficult to get good pictures from, you wouldn't 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 18 or older?
Have you been on a breathing machine for more than 2 days?
Are your doctors considering a 'breathing trial' for you?
Do you have a history of heart problems, ongoing lung disease (like COPD), or obesity?
Do you *not* have a pacemaker or severe heart valve disease?
Are you *not* pregnant and do not have a tracheostomy?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main part of your involvement would be having an echocardiogram, which is a painless ultrasound scan of your heart. This scan would be done while you are trying to breathe on your own during a 'spontaneous breathing trial' – this is a routine part of coming off a breathing machine. No extra medications or follow-up visits specifically for the study are mentioned; the study mainly involves observing your heart's function during a standard weaning test.

Potential risks and benefits

The potential benefits of this study are not for you directly, but your participation could help doctors better understand the causes of breathing difficulties when coming off a ventilator, potentially leading to improved care for future patients. The risks associated with this study are very low. The echocardiogram is a safe, non-invasive test. Your right to withdraw from the study at any time without affecting your medical care is always protected.

Locations (3)

CHU de Dijon
Verified postcode
Dijon, France· Recruiting
CHU de NICE
Verified postcode
Nice, France· Recruiting
Hôpital Cochin
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'breathing machine'?

A 'breathing machine,' also known as a ventilator, is a device that helps you breathe when you are too unwell to do so on your own.

What does 'weaning' mean?

'Weaning' is the process of gradually reducing the support from the breathing machine to help you start breathing on your own again.

What is 'weaning-induced pulmonary edema'?

It's when fluid builds up in your lungs during the process of trying to come off a breathing machine, making it hard to breathe by yourself.

What is an 'echocardiogram'?

An echocardiogram is a safe and painless type of ultrasound scan that uses sound waves to create moving pictures of your heart and how well it's pumping.

Will I get any special treatment in this study?

No, this study is observational. You'll receive your usual medical care, and the study involves taking extra measurements during standard procedures like the breathing trial.

How to find out more

Mathieu JOZWIAK, MD, PhD

jozwiak.m@chu-nice.fr 33492035510 Official trial record

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