Not yet recruitingNAINTERVENTIONAL

Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis

This research is looking into two different methods of breathing support for people who have a sudden, severe worsening of their chronic obstructive pulmonary disease (COPD) and breathing difficulties in the emergency department. These methods are called 'nasal high flow' and 'non-invasive ventilation' (NIV). The main goal is to find out if nasal high flow is as effective as NIV in helping patients (aged 18 to 85) breathe better and get their blood and breathing back to normal. Participants will be randomly assigned to receive one of these treatments. Doctors will closely monitor their progress and comfort. The study aims to improve early treatment options for these types of lung flare-ups.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

174

Start

01 Nov 2025

Estimated completion

01 Nov 2028

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Hypercapnic Acidosis Respiratory Failure With Hypercapnia

What is this study about?

This study is designed to help us understand the best way to support people who come to the emergency department with a sudden and severe worsening of their chronic obstructive pulmonary disease (COPD), often called a 'flare-up' or 'exacerbation'. These flare-ups can make it very hard to breathe, leading to too much acid in the blood (hypercapnic acidosis).

The researchers are comparing two methods of breathing support: 'nasal high flow' and 'non-invasive ventilation' (NIV). Nasal high flow delivers warmed and humidified oxygen through a hose placed in your nose. NIV uses a mask, worn over your nose and mouth, which is connected to a machine that helps you breathe. The study wants to see if nasal high flow works just as well as NIV in helping patients breathe more easily and getting their body's chemistry back in balance.

By carefully comparing these two treatments, doctors hope to find effective and comfortable ways to treat severe COPD flare-ups early on. This could lead to better and faster recovery for patients when they need urgent help with their breathing.

Key takeaways

This study compares two breathing support methods for severe COPD flare-ups.
It aims to see if 'nasal high flow' works as well as 'non-invasive ventilation' (NIV).
Participants will be randomly assigned to one treatment.
Doctors will closely monitor breathing, blood tests, and comfort.
The study takes place in the emergency department.
Standard COPD treatments will be given alongside study interventions.

Who may be eligible?

To join this study, you would need to be an adult (between 18 and 85 years old) who has been admitted to the emergency department because of a severe flare-up of your COPD. Your breathing difficulties would need to be significant enough that doctors would normally consider giving you non-invasive ventilation (NIV).

Specifically, you would need to have signs of breathing problems like fast breathing or using extra muscles to breathe, and blood tests would show too much carbon dioxide and acid in your blood. You also need to be able to understand what the study involves and agree to take part.

However, you couldn't join if you've already had NIV treatment for your current flare-up before coming to the emergency department (unless you use NIV at home regularly). Also, if there's a medical reason why NIV wouldn't be safe for you, or if you are very agitated or unwilling to try the breathing support, you wouldn't be able to participate.

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 an adult aged 18 to 85?
Are you in the emergency department for a severe COPD flare-up?
Are you having significant breathing difficulties or showing signs of respiratory failure?
Do your blood tests show too much carbon dioxide and acid?
Have you NOT already received NIV treatment for this flare-up (unless it's your home NIV)?
Can you understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either 'nasal high flow' or 'non-invasive ventilation' (NIV) to help with your breathing. This breathing support will be given in two-hour sessions, and if you need more help, these sessions can be repeated.

Throughout your time in the emergency department, doctors and nurses will closely monitor your breathing and take blood samples to check your blood's oxygen, carbon dioxide, and acid levels. This will happen at the start, after two hours, and after each two-hour breathing support session (at 2, 4, and 6 hours), and again at 24 hours. Between these breathing support sessions, you'll receive standard oxygen therapy to keep your oxygen levels steady.

We will also ask you about how breathless you feel and how comfortable you are before and during the treatment. You will receive all the usual medical treatments for a COPD flare-up, such as bronchodilators, steroids, and antibiotics. After you leave the hospital, we will follow up with you around 28 days later with a phone call or by checking your medical notes.

Potential risks and benefits

Taking part in this study means you will receive breathing support that your doctors would usually recommend for your condition. One of the potential benefits is that we might find that nasal high flow is just as effective and potentially more comfortable than standard NIV. As with any medical treatment, there can be some discomfort or mild side effects, which the medical team will monitor closely. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (3)

Centre hospitalier universitaire de Montpellier
Verified postcode
Montpellier, France
Centre hospitalier universitaire de Nimes
Verified postcode
Nîmes, France
Centre Hospitalier Universitaire de Poitiers
Verified postcode
Poitiers, France

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a group of lung conditions that cause breathing difficulties, often including emphysema and chronic bronchitis.

What is a 'flare-up' of COPD?

A flare-up, or exacerbation, is when your COPD symptoms suddenly get worse, making it much harder to breathe than usual. This often requires urgent medical attention.

What is 'nasal high flow'?

Nasal high flow is a way to give you oxygen through soft tubes placed in your nose. The oxygen is warm and moist to make it more comfortable and effective.

What is 'non-invasive ventilation' (NIV)?

NIV is a machine that helps you breathe using a mask that fits tightly over your nose and mouth. It pushes air into your lungs to make breathing easier.

Will I still get my usual medicines?

Yes, you will still receive all your normal medicines for a COPD flare-up, such as inhalers, steroids, and antibiotics, as part of your standard care.

How to find out more

Mustapha Sebbane, MD, PhD

m-sebbane@chu-montpellier.fr +33 (4) 67 33 85 76 Official trial record

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