Not yet recruitingNAINTERVENTIONAL

NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

This research is investigating the best ways to help people with interstitial lung disease (ILD) when they experience a sudden, severe worsening of their breathing, known as an acute exacerbation. ILD involves scarring of the lungs, which can make it hard to breathe. The study is comparing two different types of breathing support: non-invasive mechanical ventilation (NIV) and high-flow oxygen therapy (HFO). NIV helps push air into your lungs using a mask, while HFO delivers large amounts of warm, moist oxygen through a nasal tube. Researchers want to understand how each treatment affects your breathing effort, how well your lungs work, and your blood pressure. The aim is to find out which method provides the most effective and comfortable support during these difficult times.

At a glance

Status

Not yet recruiting

Phase

Sponsor

ADIR Association

Enrolment target

Start

01 Jan 2024

Estimated completion

31 Dec 2026

Interstitial Lung Disease Acute Respiratory Failure

What is this study about?

Imagine your lungs are like sponges, but in interstitial lung disease (ILD), they become stiff and scarred, making it harder to take a deep breath. Sometimes, this condition can suddenly get much worse, leading to severe breathing difficulties. This is called an 'acute exacerbation'. At such times, people often need extra help to breathe.

This study is looking at two common ways doctors support patients during these acute breathing crises. One is called non-invasive mechanical ventilation (NIV), which uses a tightly fitting mask over your nose or nose and mouth to gently help push air into your lungs. The other is high-flow oxygen therapy (HFO), which delivers a large amount of warm, humidified oxygen through a soft tube placed in your nostrils.

Researchers want to see exactly how these two treatments affect your body. They'll be checking things like how much effort you're putting into breathing, how well your lungs are working to get oxygen in and carbon dioxide out, and what's happening with your blood pressure. By carefully comparing these effects, the study hopes to find out which treatment is more effective and comfortable for patients with ILD during these critical times, ultimately helping doctors make better decisions about care.

Key takeaways

This study compares two common breathing supports for severe ILD flare-ups.
It aims to find which treatment works best for breathing effort and oxygen levels.
Participation involves close monitoring in intensive care.
Both treatments are standard, but the study helps doctors make better choices.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults over 18 who are currently in intensive care because their previously diagnosed interstitial lung disease (ILD) has suddenly worsened, causing severe breathing problems. You would need to have had increasing breathlessness for at least a month, and scans of your lungs (like a CT scan) that show new changes related to your ILD, not due to heart failure or too much fluid in your body. You also need to be receiving a significant amount of oxygen support, specifically more than 6 litres per minute, to help with your low oxygen levels.

There are also some reasons why you might not be able to join. For example, if you have certain medical conditions that mean you can't safely use the breathing support methods being tested, or if your condition is so critical that you immediately need a breathing tube (intubation). You also can't take part if you are very overweight (with a Body Mass Index over 40), have a pacemaker or defibrillator, or if you are pregnant or breastfeeding. Other reasons include if you are too ill or have certain skin issues where a monitoring belt would be placed. This study is not open to people who are under guardianship, deprived of liberty, or unable to have a feeding tube placed.

It's important to discuss all your medical history and current health with the study team to see if this study is suitable 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 over 18 years old?
Are you currently in intensive care for a severe worsening of your ILD?
Do you need more than 6 litres of oxygen per minute for your breathing?
Do you have new changes on your lung scans (CT scan) that are related to your ILD?
Are you able to safely receive either non-invasive ventilation or high-flow oxygen therapy?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will monitor your breathing very closely. You will receive either non-invasive mechanical ventilation (NIV) or high-flow oxygen therapy (HFO), depending on what the study assigns to you. The study involves measuring how your body responds to these treatments, including your breathing effort, blood oxygen levels, and blood pressure. This will involve the use of special monitors, possibly including a belt placed on your skin to measure lung activity. You will also have a small tube placed into your stomach through your nose, if one isn't already there. The study team will be checking on you regularly. The total duration of your active participation in the study will depend on how long you need the breathing support and intensive care, as it's directly linked to your acute breathing crisis.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main benefit here is that you would receive close medical attention and either non-invasive ventilation or high-flow oxygen therapy, which are standard treatments for your condition. Your involvement might also help future patients with ILD by providing doctors with more information about the best way to manage these severe breathing problems. Potential risks could include discomfort from the masks or nasal tubes, skin irritation from monitoring devices, or other side effects associated with the breathing support methods, although these are generally well-managed in intensive care. Please remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

ADIR Association
Verified postcode
Rouen, France

Common questions

What is interstitial lung disease (ILD)?

ILD is a group of conditions where the lungs become scarred and stiff, making it hard to breathe and get enough oxygen.

What is an 'acute exacerbation'?

This is when someone with ILD suddenly gets much worse breathing problems over a short period of time, needing urgent medical help.

What's the difference between NIV and HFO?

NIV uses a mask to gently push air into your lungs, while HFO delivers large amounts of warm, moist oxygen through a soft tube in your nose.

Will I know which treatment I'm getting?

Yes, the study team will let you know which breathing support method you are receiving as part of the study.

Who is funding this research?

The information provided does not specify the funding source for this trial.

How to find out more

Elise ARTAUD-MACARI, MD

elise.artaud-macari@chu-rouen.fr +33232885992 Official trial record

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