RecruitingInterventional

A study to see whether the lungs of very sick patients on an artificial lung machine heal more quickly with slower, deeper breathing

This study is for very sick patients in intensive care with a serious lung condition called ARDS, where the lungs are badly inflamed and struggle to get enough oxygen. These patients are supported by a heart-lung machine called ECMO. While ECMO helps the body get oxygen, patients still need a breathing machine (ventilator). We want to find out if giving the lungs more rest, by using only a couple of slow, deeper breaths per minute on the ventilator, helps them recover quicker than the usual way of breathing. We hope this could reduce the time patients need ECMO and the ventilator, and improve their long-term recovery and quality of life. This research might help future patients with similar conditions.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

364

Start

05 Jan 2026

Estimated completion

31 Oct 2028

Acute respiratory distress syndrome (ARDS)

What is this study about?

When people get very sick, their lungs can become severely inflamed and injured in a condition called Acute Respiratory Distress Syndrome (ARDS). This makes it really hard for their body to get enough oxygen. ARDS can be caused by serious infections like pneumonia, or other major illnesses. People with severe ARDS often need a breathing machine, called a ventilator, to help them. If they're still struggling, they might need an additional machine called ECMO (Extracorporeal Membrane Oxygenation), which acts like an artificial lung, taking over the job of adding oxygen to the blood and removing carbon dioxide. This allows the medical team to reduce the support the ventilator gives, hoping to give the patient's own lungs a chance to rest and heal.

While ventilators are life-saving, they can sometimes cause further damage to the lungs if the breathing settings aren't just right. When a patient is on ECMO, the machine is doing most of the work to oxygenate the blood. This study wants to explore if giving the lungs even more rest, by having the ventilator deliver only two slow, deeper breaths (we call these 'sigh breaths') per minute, is better than the usual way doctors set the ventilator (which can be between 10 to 30 breaths per minute). Our main goal is to see if these very slow, deep breaths allow the lungs to recover faster and reduce the harm a ventilator might cause.

By helping the lungs heal quicker, we hope patients might need ECMO and the ventilator for less time. This could lead to fewer complications, shorter stays in the intensive care unit, and better overall recovery for people who have been through this very serious illness. The results of this study could help doctors worldwide find the best way to support patients with severe ARDS who are on ECMO, improving their care in the future.

Key takeaways

Looks at how different breathing machine settings affect lung healing in very sick patients on ECMO.
Aims to see if giving lungs more rest with 'sigh breaths' helps them recover faster.
Could reduce time needed on ECMO and breathing machines.
Patients are randomly assigned to one of two ventilation groups.
Information gathered may help improve care for future patients.
Risks are considered low, as ECMO is doing most of the lung's work.

Who may be eligible?

This study is looking for adults aged 18 or older who are currently in intensive care and need a breathing machine because of severe ARDS. They must be considered for or already be receiving ECMO treatment.

Some people may not be able to join. For example, if they have been on the ECMO machine for more than two days, or if the medical team believes they are unlikely to survive for more than 48 hours. Also, people with a specific lung problem called a bronchopleural fistula cannot take part.

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?
Are you currently receiving breathing support with a ventilator for severe ARDS?
Are you considered for or already receiving ECMO treatment?
Have you been on ECMO for less than 48 hours?
Do you not have a specific lung problem called a bronchopleural fistula?

Answer every question to see your result.

What does participation involve?

If you or your loved one joins this study, you will be randomly placed into one of two groups, like flipping a coin. You might not know which group you are in, but the medical team will. One group will receive special ventilation with only two deep 'sigh breaths' per minute for the first three days on ECMO, while the other group will receive standard ventilation. After three days, the medical team will decide how to continue the ventilator settings based on how the lungs are recovering.

We will also ask if you agree to provide small blood and lung fluid samples. These samples will be taken at the same time as routine tests, so no extra needles are needed. The doctors and nurses will record information about your ventilator and ECMO settings, observations like blood pressure, and all the medications and treatments you receive. This information is already part of your usual care, and we will just collect parts of it that are important for the study.

The research team will check on you daily while you are in the intensive care unit. Once you leave the ECMO ICU and are discharged to another hospital, we will follow up again before you leave that hospital. We will then follow up at 6 and 12 months after discharge using questionnaires (sent by post, email, or over the phone) and by looking at your medical records where possible.

Potential risks and benefits

We can't promise that you will directly benefit from being in this study. However, the information gathered could significantly help future patients who develop severe ARDS and need ECMO, potentially leading to better treatments and reduced complications. Your participation could improve our understanding of how different breathing supports affect lung healing. The risks of receiving only two breaths per minute on the ventilator are low because the ECMO machine is doing most of the work for your lungs. Risks from blood and lung fluid samples are also very low, as these are taken during routine procedures. You are free to withdraw from the study at any time without affecting your medical care.

Locations (9)

Guy's and St Thomas' NHS Foundation Trust
City only
London, England
Royal Papworth Hospital NHS Foundation Trust
City only
Cambridge, England
King's College Hospital NHS Foundation Trust
City only
London, England
Grampian
Approximate
Aberdeen, Scotland
University Hospitals of Leicester NHS Trust
City only
Leicester, England
Manchester University NHS Foundation Trust
City only
Manchester, England
University Hospitals Bristol and Weston NHS Foundation Trust
City only
Bristol, England
Barts Health NHS Trust
City only
London, England
Guy’s and St Thomas’ NHS Foundation Trust
City only
London, England

Common questions

What is ARDS?

ARDS (Acute Respiratory Distress Syndrome) is a serious condition where your lungs become inflamed and injured, making it hard to breathe and get enough oxygen.

What is ECMO?

ECMO is a special machine that acts as an artificial lung and sometimes heart. It takes over the job of oxygenating your blood so your own lungs and heart can rest and heal.

What is a 'sigh breath'?

A 'sigh breath' is a slow, deeper breath given by the ventilator, designed to gently keep the lungs open and prevent them from collapsing.

Will I know which treatment group I'm in?

No, you will be randomly assigned to a group, and you won't know which one. This helps us ensure the study results are fair and unbiased.

Who is funding this study?

This study is funded by the National Institute of Health Research (NIHR) in the UK.

How to find out more

Brijesh Patel

brijesh.patel@imperial.ac.uk +44 (0)2073528121 Official trial record

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