RecruitingNAINTERVENTIONAL

Fluid Responsiveness Prediction During Prone Position

Doctors often need to give fluids to very sick patients with serious breathing issues (Acute Respiratory Distress Syndrome or ARDS) who are being treated by lying on their stomachs (prone position). Giving the right amount of fluid is crucial – too little means organs might not get enough blood, but too much can make breathing worse and lead to other problems. Currently, it's hard to tell who needs fluids when they're in this position. This study is testing four simple ways to predict if a patient will respond well to extra fluids. These tests involve gentle body movements or breathing checks. The goal is to find the most accurate test, so doctors can make better decisions about fluid treatment, helping these vulnerable patients recover more safely and effectively.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

06 Oct 2023

Estimated completion

01 Oct 2026

Acute Respiratory Distress Syndrome

What is this study about?

When someone is very unwell and their body isn't getting enough blood flow, it's called circulatory shock. Doctors often try giving extra fluids to help. However, giving too much fluid can be harmful, especially for patients with severe breathing difficulties, like those with Acute Respiratory Distress Syndrome (ARDS).

ARDS is a serious lung condition where the lungs become inflamed and filled with fluid. A common treatment for severe ARDS is to lie the patient on their stomach (prone position) to help them breathe better. The challenge is, when patients are in this prone position, it's very difficult for doctors to figure out if more fluids will actually help their heart pump better, or if it will just make their breathing problems worse by adding more fluid to their lungs.

This study is comparing four different, quick tests to see which one can best predict if a patient with severe ARDS, who is lying on their stomach, would benefit from receiving more fluids. These tests involve small, temporary changes, like gently shifting body position or briefly pausing breathing. By finding an accurate test, doctors can give fluids more precisely, improving care and avoiding potential harm from too much fluid.

Key takeaways

This study helps doctors decide if critically ill patients need more fluids.
It focuses on patients with severe breathing problems (ARDS) who are lying on their stomachs.
We are comparing four quick, gentle tests to find the most accurate one.
The goal is to improve safety and effectiveness of fluid treatment in these patients.
Your direct participation in the study is very brief (around 30 minutes).

Who may be eligible?

To be part of this study, you would need to be an adult patient (18 years or older) with severe breathing difficulties (ARDS) who is currently being treated by lying on your stomach. Doctors would also need to feel you might benefit from receiving some extra fluids, based on several signs like a fast heart rate or low blood pressure. You would also need to have a special device monitoring your heart's output.

There are also some reasons why you couldn't join the study. These include if you have certain heart conditions (like acute cor pulmonale), are experiencing active bleeding, have severe liver disease, or if doctors expect your condition to be life-limiting within 24 hours. If you've previously been in this exact study or are pregnant, you also wouldn't be able to participate. The medical team will check all these points to see if the study is right for you.

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?
Do you have severe breathing problems (ARDS)?
Are you currently being treated by lying on your stomach?
Does your doctor think you might need extra fluids?
Do you have a special monitor for your heart's output?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, your participation will be very brief. Over about 30 minutes, you will go through four different quick tests, which might involve gentle changes in your body position or short pauses in your breathing. Each test is followed by a short break to make sure your body returns to its normal state before the next test. At the very end, doctors will give you a small amount of fluid (about half a litre, which is like two full cups) through your existing IV line, as they would typically do if you needed it. You will only participate in the study once.

Potential risks and benefits

The main benefit of this study is that it will help doctors in the future make better and safer decisions about giving fluids to critically ill patients. There are no direct benefits for you as a participant beyond the usual care you would receive. The tests themselves are generally considered safe and minimal risk, as they involve standard medical procedures or gentle, temporary changes. You will, of course, continue to receive your usual medical care throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical treatment.

Locations (4)

CHU Gabriel Montpied
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
Hôpital de la Croix Rousse, Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
CHU de Nice - l'Archet 1
Verified postcode
Nice, France· Not yet recruiting
CHU Nice - Pasteur 2
Verified postcode
Nice, France· Not yet recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where fluid builds up in the air sacs, making it very hard to breathe.

Why do I need to be on my stomach (prone position)?

Lying on your stomach helps some patients with severe ARDS breathe better by allowing more air into parts of the lungs that might otherwise be squashed.

What is 'fluid responsiveness'?

Fluid responsiveness means whether your heart and blood circulation would improve if you were given extra fluids through an IV. It's about finding the right balance.

Are the tests painful?

The tests involve gentle changes like body positioning or brief breathing pauses. They are not expected to be painful, and you will be closely monitored by medical staff.

How long does the study last for me?

Your involvement in the study will be very short, typically lasting no more than 30 minutes in total, and you only participate once.

How to find out more

Laurent BITKER, Dr

laurent.bitker@chu-lyon.fr 4 26 10 94 93 Official trial record

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