CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases
This study aims to find the best way to help people having a very severe flare-up of chronic obstructive pulmonary disease (COPD). It compares the usual care with a new method called ECCO2R, which helps remove carbon dioxide from the blood. Researchers want to see if adding ECCO2R makes a difference in how well patients recover and if it's safe. They are focusing on patients who are at high risk of not responding to standard breathing support or who are already on a breathing machine. The goal is to improve breathing and survival for those with the most serious COPD emergency.
At a glance
What is this study about?
If you have severe COPD, you might sometimes experience sudden flare-ups (called acute exacerbations) where your breathing becomes much worse. This study is designed to explore the most effective ways to treat these very serious flare-ups. Doctors want to compare current standard care with a treatment that helps remove extra carbon dioxide from your blood, called ECCO2R. They believe this extra help might make it easier for your lungs to recover and could prevent some of the more serious problems that can happen during a severe COPD flare-up.
The study is looking at two main groups of patients. One group includes those who are at a high risk of not improving with common breathing support methods. The second group includes patients who are already very unwell and need a breathing machine. For both groups, the aim is to see if adding the ECCO2R treatment leads to better outcomes, such as breathing more easily, spending less time on a breathing machine, and ultimately, improving recovery and survival.
By comparing these treatments carefully, doctors hope to gain a clearer understanding of how to best manage these life-threatening COPD emergencies. This research is important because it could lead to new and improved ways of caring for patients when they are at their sickest, helping them recover more safely and effectively.
Key takeaways
- This study evaluates new severe COPD flare-up treatments.
- It compares standard care with ECCO2R (carbon dioxide removal).
- Aims to improve breathing and recovery for very sick patients.
- Participation involves close monitoring in the ICU and phone follow-ups.
- You have the right to leave the study at any time.
Who may be eligible?
To be part of this study, you need to be at least 18 years old and have a known or suspected diagnosis of COPD. Your breathing must have gotten significantly worse for less than two weeks, and you need to be experiencing a very severe flare-up.
Specifically, a very severe flare-up means either: your carbon dioxide levels are very high and your blood is too acidic, even after some initial breathing support; OR you've been put on a breathing machine within the last 72 hours, possibly after other breathing support didn't work, and you still have high carbon dioxide levels and issues with lung overinflation.
There are also some reasons you wouldn't be able to join. These include having unstable blood pressure, certain bleeding problems or disorders, allergies to specific medications like heparin, or if you've recently had major surgery. You also can't take part if you have certain other serious health conditions, are severely frail, have a very high body mass index, or if you have made a decision not to be put on a breathing tube.
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 COPD and a severe flare-up right now?
- Has your breathing gotten much worse within the last two weeks?
- Are you currently in a very serious condition due to your COPD?
- Are you able to provide consent, or can someone legally do it for you?
- Do you have stable blood pressure and no specific bleeding disorders?
What does participation involve?
If you join this study, it will last for about one year. In the beginning, you'll have several checks, including physical exams, blood tests, and heart tracings, to make sure you're suitable for the study. Once you're in, you will be randomly assigned to receive either the standard care or the standard care plus the ECCO2R treatment to help remove carbon dioxide.
Throughout your time in the Intensive Care Unit (ICU), and up to 28 days after you're chosen for the study, you'll have daily visits. During these visits, doctors and nurses will check your breathing, your vital signs, any medications you're taking, and record if you experience any side effects. They'll also take daily blood samples.
After you leave the ICU (or after 28 days, whichever comes first), you'll have follow-up evaluations at 60 days, 90 days, 180 days, and a year after joining the study. These follow-ups will mostly be by phone to check how you are doing, your overall health, and your ability to carry out daily activities.
Potential risks and benefits
Locations (20)
- CHU AngersVerified postcodeAngers, France
- CHU BesançonVerified postcodeBesançon, France
- Hôpital Avicennes, AP-HPVerified postcodeBobigny, France
- CHD de VendéeVerified postcodeLa Roche-sur-Yon, France
- CH Le MansVerified postcodeLe Mans, France
- Hôpital de la Croix-RousseVerified postcodeLyon, France
- Hôpital NordVerified postcodeMarseille, France
- CHU LapeyronieVerified postcodeMontpellier, France
- CHR OrléansVerified postcodeOrléans, France
- Hôpital La Pitié Salpêtrière, AP-HPVerified postcodeParis, France
- Hôpital Cochin - APHPVerified postcodeParis, France
- Hôpital européen Georges Pompidou - APHPVerified postcodeParis, France
Common questions
What is COPD?
COPD is a chronic lung disease that makes it hard to breathe. It includes conditions like emphysema and chronic bronchitis.
What is an 'acute exacerbation'?
This is a sudden worsening of your COPD symptoms, like breathlessness and cough, which can be very serious and requires urgent medical attention.
What does 'ECCO2R' mean?
It stands for ExtraCorporeal CO2 Removal. It's a treatment that helps remove excess carbon dioxide from your blood, similar to how a dialysis machine works for kidneys.
Will I definitely receive the new treatment?
No, participants are randomly assigned to either receive the standard care or the standard care plus the ECCO2R treatment, like flipping a coin, so it's fair.
Will I have to pay to be in the study?
No, your social security system will cover your medical care for the conditions studied, so there won't be any extra costs for you to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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