RecruitingOBSERVATIONAL

EIT Assessment of Overdistension in ARDS Patients in Prone Position

This study is for patients in intensive care with a serious lung condition called Acute Respiratory Distress Syndrome (ARDS), who need help breathing with a machine. When these patients lie on their front (called 'prone position'), it can help their lungs. We're using a special, harmless scanning belt called Electrical Impedance Tomography (EIT) to get a clear picture of how air moves in their lungs. The main goal is to help doctors find the best settings for the breathing machine. We want to make sure enough air gets into the lungs without accidentally stretching other parts too much, which can cause damage. We're looking at how to balance opening up collapsed lung areas with protecting healthy areas, both before and after patients are turned onto their front.

At a glance

Status

Recruiting

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

15 Oct 2024

Estimated completion

01 May 2026

Acute Respiratory Distress Syndrome

What is this study about?

When someone has a severe lung condition called Acute Respiratory Distress Syndrome (ARDS), their lungs can become very stiff and damaged, making it hard to breathe. They need a breathing machine, also known as a ventilator, to help them. A key part of using a breathing machine is finding the right pressure setting, called PEEP. Think of PEEP like adding a little bit of air at the end of each breath to keep tiny air sacs in your lungs open. Sometimes, lying on your front, known as the 'prone position,' can also help improve breathing by allowing more parts of the lung to open up.

However, finding the perfect PEEP setting can be tricky. While PEEP can help open up collapsed parts of the lung, mainly at the back, there's a risk of stretching other, healthier parts of the lung too much. This overstretching can cause more damage. This study uses a special, non-invasive (meaning it doesn't go inside your body) technique called Electrical Impedance Tomography, or EIT. It's like wearing a special belt around your chest that creates a picture of how air is moving inside your lungs.

The main aim of this study is to use this EIT belt to help doctors see what's happening with your lungs in real-time. By doing this, they can better adjust the breathing machine settings. The goal is to find the 'sweet spot' for PEEP – a setting that helps open up as many collapsed lung areas as possible while making sure other, healthier parts of the lung aren't stretched too much. We'll be looking at these changes before and after patients are turned onto their front.

Key takeaways

The study helps doctors find the best breathing machine settings for ARDS patients.
It uses a special chest belt (EIT) to see how lungs are working.
The goal is to balance opening up lungs without causing damage.
Measurements are taken before and after patients are turned onto their front.
Participation involves no extra medication, just monitoring during standard care.

Who may be eligible?

This study is for adult patients (aged 18 or over) who are currently in intensive care. They must have a serious lung condition called Acute Respiratory Distress Syndrome (ARDS) and need to be on a breathing machine. They will also need to be sedated (given medicine to make them sleep) and given medicines to relax their muscles during this time. A special EIT belt will be fitted around their chest.

There are certain reasons why someone might not be able to join the study. For example, if they have holes in their lungs, are pregnant or breastfeeding, or have certain medical devices like a pacemaker that could interfere with the EIT belt. Also, if there are practical reasons that prevent the EIT belt from being placed correctly, such as tubes coming out of the chest or large dressings, they 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 years old or older?
Are you currently in intensive care for severe ARDS?
Are you on a breathing machine, sedated, and receiving muscle relaxants?
Do you have a pacemaker, defibrillator, or unstable spine problem?
Do you have any medical conditions or chest dressings that would prevent a belt from being placed correctly around your chest?

Answer every question to see your result.

What does participation involve?

If you were to take part, the main part of the study involves using the special EIT belt around your chest while you are already on a breathing machine in intensive care. The study measurements would happen at two specific times: once before you are potentially turned onto your front, and then again shortly after you have been turned onto your front. During these times, the medical team would adjust the breathing machine settings (specifically, the PEEP level) in a step-by-step way while using the EIT belt to see how your lungs respond. This process helps them find the best settings for you. There are no additional medications given specifically for this study, and the overall duration of the study measurements would be during your existing treatment in intensive care.

Potential risks and benefits

Taking part in this study may offer the benefit of helping your medical team find the most appropriate settings for your breathing machine, potentially improving how your lungs are supported. However, as with any medical procedure, there are minor risks. Placing the EIT belt is generally safe, but there's a small chance of skin irritation. Adjusting breathing machine settings always carries slight risks, which your medical team is trained to manage. You, or your legal representative, always have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

CH Cote Basque
Verified postcode
Bayonne, France· Recruiting
Hopital Haut-Lévêque
Verified postcode
Pessac, France· Recruiting

Common questions

What is ARDS?

ARDS (Acute Respiratory Distress Syndrome) is a severe lung condition where the lungs become inflamed and filled with fluid, making it very hard to breathe on your own.

What is a 'breathing machine'?

A breathing machine, or ventilator, is a medical device that helps you breathe when your lungs are too sick to do it properly by themselves. It pushes air into your lungs.

What is 'prone position'?

Prone position means lying on your front. For some patients with ARDS, this position can help certain parts of their lungs open up and improve breathing.

What is the EIT belt?

The EIT belt is a special, harmless belt worn around your chest. It uses a very small electric current to create a picture of how air is moving inside your lungs in real-time.

Will I feel anything from the EIT belt?

No, you will not feel anything from the EIT belt. It’s non-invasive and the electrical currents are very weak and cannot be felt by a patient.

How to find out more

Benjamin REPUSSEAU, Dr

benjamin.repusseau@chu-bordeaux.fr 05 57 65 68 66 Official trial record

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