RecruitingNAINTERVENTIONAL

Inflammation During ECMO Therapy and ECMO Weaning

This research is looking for the best step-by-step approach to help patients with severe lung failure, called Acute Respiratory Distress Syndrome (ARDS), recover. These patients are supported by a special heart-lung machine called ECMO and a breathing machine (ventilator). The study divides patients into two groups. One group will be taken off the breathing machine first, before gradually stopping ECMO. The other group will have ECMO stopped first, then the breathing machine. The main goal is to find out which method causes less inflammation in the lungs, reduces side effects, and generally leads to a smoother recovery. Researchers will measure inflammation markers in the blood and track other health indicators like how well the lungs are working, how long patients stay in intensive care, and if they develop infections.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

Start

01 Jan 2023

Estimated completion

01 Dec 2026

Acute Respiratory Distress Syndrome

What is this study about?

This study is designed to help patients who have a very serious lung condition called Acute Respiratory Distress Syndrome (ARDS). With ARDS, the lungs are severely damaged and can't provide enough oxygen to the body. To help these patients, doctors sometimes use special machines: a ventilator, which is a breathing machine, and occasionally ECMO. ECMO is a more advanced machine that takes over the work of the lungs (and sometimes the heart) while the lungs heal.

The main question we're trying to answer is: what's the best order to take patients off these machines once their lungs start to get better? Should we try to wean someone off the breathing machine (ventilator) first, and then gradually stop the ECMO machine? Or is it better to stop the ECMO machine first, and then focus on weaning them off the ventilator?

We believe that one of these approaches might put less stress on the recovering lungs, leading to less inflammation. Inflammation can slow down healing and cause other problems. By finding the gentlest way, we hope to improve recovery, reduce complications, and help patients get out of intensive care sooner. We'll be looking closely at signs of inflammation in the blood, how well the lungs are working, and a patient's overall health during their time in hospital.

Key takeaways

Tests different strategies for taking patients off ECMO and ventilators.
Aims to find the gentlest way to help lungs recover.
Will measure inflammation and overall patient health.
Involves patients with severe lung failure (ARDS).
Participation requires consent from patient or legal representative.

Who may be eligible?

To join this study, adult patients must have severe lung failure (ARDS) and be receiving support from a special machine called ECMO. They need to be in a stable condition and their lungs should have shown some signs of improvement or stability in the last 24 hours. Crucially, the patient or their legal representative must agree to take part.

However, some people won't be able to join. This includes anyone under 18, or if they've been on a breathing machine for more than 7 days before starting ECMO. If a patient or their family decides against full intensive care treatment, or if a woman is pregnant, they can't participate. Also, patients with certain heart problems requiring a different type of ECMO, or those with long-term breathing difficulties needing oxygen at home, won't be eligible.

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 or older?
Do you have severe lung failure and are currently on ECMO?
Have your lungs shown some stability or improvement recently?
Are you (or your legal representative) able to give consent?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you will be randomly placed into one of two groups. One group will try coming off the breathing machine (ventilator) before ECMO, and the other will try coming off ECMO before the ventilator. Doctors will closely monitor your progress using blood tests to check for inflammation, and also track how your lungs are working, your overall health scores, and how long you stay in intensive care. All of these measurements are part of the standard care you would receive anyway, but in this study, the timing of weaning will be specifically managed. The study will continue as long as you are receiving intensive care for your ARDS, and you'll be followed up through your hospital stay.

Potential risks and benefits

The potential benefit of taking part is that the specific weaning strategy you receive might lead to less inflammation, a smoother recovery, and fewer complications compared to the usual approach. However, there's always a possibility that the strategy you're assigned doesn't work as well as hoped, or for some individuals, it might even lead to temporary setbacks. All medical interventions carry some risks. Your medical team will carefully monitor you throughout. You have the right to withdraw from the study at any time without affecting the quality of your medical care, and your doctors will continue to provide the best possible treatment for you.

Locations (1)

University Hospital Tuebingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where your lungs are badly damaged and can't get enough oxygen into your blood.

What is ECMO?

ECMO is a special machine that acts like an artificial lung (and sometimes heart) outside your body. It takes over the work of your lungs so they can rest and heal.

What is a ventilator?

A ventilator is a breathing machine that helps push air into and out of your lungs when you can't breathe well enough on your own.

Will I get to choose which weaning group I'm in?

No, you will be randomly assigned to one of the two groups, like flipping a coin. This helps make the study fair and scientific.

What does 'inflammation' mean in this study?

Inflammation is your body's natural response to injury or infection. In this study, we're looking for signs of too much inflammation in the lungs, which can slow down healing.

How to find out more

Peter Rosenberger, Prof.

peter.rosenberger@med.uni-tuebingen.de +49707129 Official trial record

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