RecruitingPHASE3INTERVENTIONAL

"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"

The CALMDOWN study is looking into a different way to help people with a very serious lung condition called Acute Respiratory Distress Syndrome (ARDS). When ARDS is severe, some patients need a special machine called ECMO to help them breathe. This study compares two ways of using the ECMO machine: one where the patient's breathing is kept very quiet (near apneic ventilation), and another using standard, gentle breathing (ultra-protective lung ventilation). The main goal is to see if nearly resting the lungs completely with the first method can help protect them better, shorten the time patients need the ECMO machine, and improve their chances of survival. It’s an important study to find the best way to care for patients with very severe ARDS.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

280

Start

06 May 2025

Estimated completion

06 May 2030

Acute Respiratory Distress Syndrome Extracorporeal Membrane Oxygenation Complication

What is this study about?

Imagine your lungs are very sick and struggling to breathe, even with a normal breathing machine. This condition is called Acute Respiratory Distress Syndrome, or ARDS. When ARDS is very severe, doctors sometimes use a special machine called ECMO. This machine works outside your body, taking over the job of your lungs by adding oxygen to your blood and removing carbon dioxide, giving your lungs a chance to rest and heal.

This study, called CALMDOWN, is looking for the best way to use the ECMO machine to help people with severe ARDS. Doctors want to know if letting the lungs rest almost completely – by keeping breathing very quiet, sometimes called 'near apneic ventilation' – is better than the current standard approach, which uses gentle breathing settings. The idea is that if the lungs don't have to work hard at all, they might get injured less and recover more quickly. While on ECMO, patients are still connected to a breathing machine to support healing, but the settings are adjusted differently.

The aim is to find out if this 'near apneic' approach can help people get off the ECMO machine sooner and improve their overall chances of recovery. This is particularly for patients who are already on ECMO because their ARDS is so serious. By carefully comparing these two methods, researchers hope to improve care for future patients facing this life-threatening condition.

Key takeaways

This study compares two ways of using an ECMO machine for severe lung disease (ARDS).
It aims to see if resting the lungs more completely can help them heal faster.
Participation involves being randomly assigned to one of two care groups while in intensive care.
The goal is to improve recovery and survival for very ill patients.
Your decision to join or not will not affect your standard medical care.
The study lasts up to 60 days following your inclusion.

Who may be eligible?

This study is for adults aged 18 or older who have developed very severe Acute Respiratory Distress Syndrome (ARDS) and have recently started treatment with an ECMO machine. To be considered, you must have begun ECMO within the last 48 hours.

There are also some situations that would mean you couldn't join the study. For example, if you are pregnant or breastfeeding, or if you have certain other serious health issues like severe (end-stage) lung disease or advanced liver problems.

Finally, if you've recently had a serious heart attack with a long period where your heart stopped, or if you have certain brain conditions that are irreversible, you wouldn't be able to take part. Researchers also cannot include people who are already in another similar study or those who have certain conditions that might make the study treatment unsafe, like previous lung injuries that would make high breathing pressures risky.

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 Acute Respiratory Distress Syndrome (ARDS)?
Have you started ECMO treatment within the last 48 hours?
Are you not pregnant or breastfeeding?
Do you not have certain other serious health issues like advanced liver or lung disease?
Are you not currently part of another similar medical study?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive the 'near apneic ventilation' approach, where your breathing machine settings are adjusted to give your lungs maximum rest while on ECMO. The other group will receive the standard 'ultra-protective lung ventilation' approach, which also aims to protect the lungs but uses different settings.

Both groups will continue to receive the best possible medical care for their ARDS while on the ECMO machine. The study will mainly involve monitoring your condition closely while you are already in intensive care. Researchers will collect information on how long you need the ECMO machine, how well your lungs recover, and your overall health outcomes up to 60 days after joining the study. You won't need to attend extra hospital visits or take additional medication specifically for the study. The total duration of your participation in the study's data collection would be up to 60 days.

Potential risks and benefits

Taking part in any medical study carries potential benefits and possible risks. The potential benefit of this study is that the 'near apneic' ventilation method might lead to better lung recovery, a shorter time on ECMO, and improved survival compared to current standard care for severe ARDS. However, it's also possible there might be no difference, or even that the new method could have unforeseen disadvantages, although the research team is carefully monitoring for this. Because you are already very unwell, any risks primarily relate to the monitoring and interventions that would be part of your standard intensive care, rather than additional procedures for the study. You are always free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (11)

Avicenne Hospital
Verified postcode
Bobigny, France· Recruiting
Haut Levèque Hospital - CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Henri Mondor Hospital
Verified postcode
Créteil, France· Recruiting
Croix-Rousse Hospital - HCL
Verified postcode
Lyon, France· Recruiting
North Hospital - APHM
Verified postcode
Marseille, France· Recruiting
Mercy Hospital - CHR Metz
Verified postcode
Metz, France· Recruiting
Brabois Hospital - CHRU Nancy
Verified postcode
Nancy, France· Recruiting
CHU Orléans
Verified postcode
Orléans, France· Recruiting
Pitié-Salpêtrière Hospital
Verified postcode
Paris, France· Recruiting
Pontchaillou Hospital - CHU Rennes
Verified postcode
Rennes, France· Recruiting
CHU Tours
Verified postcode
Tours, France· Recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a very serious lung condition where fluid builds up in your lungs, making it hard to breathe and get enough oxygen into your blood.

What is ECMO?

ECMO is a special machine that acts like an artificial lung and heart outside your body. It takes over the work of your lungs so they can rest and heal, usually in very serious cases of ARDS.

What does 'randomly assigned' mean?

It means you would be put into one of the two study groups by chance, like drawing a name from a hat or flipping a coin. Neither you nor the doctors can choose which group you are in.

Will I get different care if I don't join the study?

No, you will always receive excellent medical care regardless of whether you choose to participate in the study. Your decision won't affect your treatment.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical treatment.

How to find out more

Matthieu SCHMIDT, MD

matthieu.schmidt@aphp.fr 01 42 16 29 37 Official trial record

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