RecruitingNAINTERVENTIONAL

Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

This study is for people having major lung surgery who are considered high-risk. When you have surgery, doctors give you fluids to keep you stable. This study wants to see if using a new device called 'chest bioreactance' to guide how much fluid is given can lead to better recovery. This monitor helps doctors know exactly how much fluid your body needs. Currently, standard fluid management might sometimes lead to too much or too little fluid, which can cause complications. By using this personalised approach, researchers hope to reduce the chances of problems after surgery within the first 30 days. One group will get this special fluid guidance, and another will receive the usual care.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

722

Start

12 Dec 2024

Estimated completion

01 Jan 2027

High-risk Lung Resection Surgery

What is this study about?

When you have a big operation like lung surgery, your body needs careful management, especially with the fluids given during the procedure. Sometimes, getting too much or too little fluid can lead to complications afterwards. This is even more important for patients who are considered high-risk.

Doctors currently use standard methods to decide how much fluid to give. However, this study is exploring a new, more personalised approach. It uses a special, non-invasive monitor worn on the chest, called 'chest bioreactance'. This device gives doctors continuous information about how your heart is pumping and how much fluid is in your body. This allows them to adjust the fluids you receive in a much more tailored way, aiming to keep your fluid levels just right throughout the surgery.

The main goal of this study is to see if using this personalised fluid management system, guided by the chest bioreactance monitor, leads to fewer complications within the first 30 days after lung surgery, compared to patients who receive standard fluid care. This could potentially make your recovery smoother and safer.

Key takeaways

The study aims to improve recovery for high-risk lung surgery patients.
It tests a new, personalised way of managing fluids during surgery.
A special chest monitor helps guide fluid amounts, aiming for fewer complications.
Patients will be randomly assigned to either new fluid guidance or standard care.
The study measures complications and recovery for 30 days after surgery.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and be scheduled for lung surgery. This could be open surgery or keyhole surgery (video-assisted or robotic).

You're considered high-risk for this study if you have certain health conditions, like significant breathing problems, a higher risk of kidney injury, or other specific health markers that doctors use to assess risk.

However, you won't be able to join if you're having emergency surgery, if you've had certain other types of chest surgery recently, or if you're already in another study that might affect these results. Pregnant or breastfeeding women, or women who could become pregnant and are not using effective contraception, also cannot participate. You must also be able to understand what the study involves and have typical health insurance.

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 lung removal surgery (not emergency surgery)?
Have your doctors told you that you are considered a high-risk patient for surgery?
Are you able to understand what this research study involves and willing to give your consent?
Are you male, or if female, are you not pregnant, breastfeeding, or could become pregnant and are using effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive fluid management that is guided by the new chest bioreactance monitor during your lung surgery. The other group will receive the usual standard fluid care, without this special monitor.

After your surgery, the research team will carefully track your recovery and any complications you might experience for up to 30 days. This will involve reviewing your medical records. You won't need extra tests or procedures beyond your usual surgical care. An independent committee, who won't know which group you were in, will help judge the results to ensure fairness. The total duration of your active participation, for data collection, will be the 30 days following your surgery.

Potential risks and benefits

Taking part in this study may offer potential benefits, as the personalised fluid management could lead to a smoother recovery and fewer complications after surgery, though this is not guaranteed as it is still being investigated. For those in the standard care group, you will receive the usual care. Potential risks are generally low, as the chest bioreactance device is non-invasive and considered safe; it simply monitors information and doesn't involve new medications or invasive procedures. As with any medical study, you have the right to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (10)

Hopital Louis Pradel
Verified postcode
Bron, France· Recruiting
CHU Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting
Hôpital Arnaud de Villeneuve - CHU Montpellier
Verified postcode
Montpellier, France· Recruiting
Chu Nancy
Verified postcode
Nancy, France· Recruiting
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France· Recruiting
Hopital du Haut-Leveque - CHU Bordeaux
Verified postcode
Pessac, France· Recruiting
CHU de Rennes
Verified postcode
Rennes, France· Recruiting
CHU Nantes
Verified postcode
Saint-Herblain, France· Recruiting
CHU Strasbourg
Verified postcode
Strasbourg, France· Recruiting
Chu Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is 'high-risk' surgery?

High-risk means your doctors have identified certain health factors that might make your surgery or recovery more challenging than usual.

What is 'chest bioreactance'?

It's a non-invasive device, placed on your chest, that helps doctors continuously measure how well your heart is pumping and your body's fluid levels during surgery.

Will I know which group I'm in?

You won't be told if you're receiving the special fluid guidance or standard care, to ensure the study results are as unbiased as possible.

How long will the study follow me?

The study team will monitor your recovery and any complications for 30 days after your surgery.

Will this involve extra appointments?

No, your participation will mainly involve monitoring during and shortly after your surgery, with no extra clinic visits or tests beyond your usual care.

How to find out more

FELLAHI Jean-Luc, M.D., Ph.D.,

jean-luc.fellahi@chu-lyon.fr (+33) 4 72 11 89 33 Official trial record

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