RecruitingNAINTERVENTIONAL

Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO

This study helps doctors understand the best way to use breathing machines for patients with severe lung injury, called ARDS, who are also on a life support system called ECMO. Doctors are using a very gentle approach to breathing machine settings, known as 'ultra-protective ventilation,' to try and protect the patient's lungs. However, sometimes these very gentle settings might cause parts of the lung to close up. This study uses a special scanning technique called Electrical Impedance Tomography (EIT) to get a real-time picture of how the lungs are behaving with these gentle settings. The main goal is to find the perfect balance that protects the lungs from damage while making sure they don't collapse. We also want to see how adjusting another breathing machine setting, called PEEP, can help keep the lungs open.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

11 Mar 2023

Estimated completion

11 May 2027

Severe ARDS

What is this study about?

When someone has very severe lung injury, known as Acute Respiratory Distress Syndrome (ARDS), their lungs struggle to get enough oxygen into their blood. Sometimes, a life support machine called ECMO (Extracorporeal Membrane Oxygenation) is needed to give the lungs time to heal. Even with ECMO, patients still need a breathing machine, called a ventilator.

Doctors try to use very gentle ventilator settings, known as 'ultra-protective ventilation,' to avoid further damage to the delicate lungs. This often means using very small breaths, called 'tidal volumes.' While good for protecting the lung from too much stretch, there's a concern that these very small breaths might cause parts of the lung to gently close up, which isn't ideal. This study aims to find the 'sweet spot' for these settings.

To do this, we'll be using a special technique called Electrical Impedance Tomography (EIT). Think of EIT as a harmless way to see how air moves in and out of the lungs in real-time, like a live map. This helps doctors see if parts of the lung are collapsing or getting too stretched. By carefully adjusting the ventilator settings step-by-step and watching the EIT scan, doctors hope to find the best way to help the lungs recover, balancing protection with keeping them open and healthy. We'll also look at another ventilator setting called PEEP (Positive End Expiratory Pressure), which helps keep the air sacs open at the end of each breath, to see if it can prevent any lung collapse.

Key takeaways

Study for severe lung injury (ARDS) patients on ECMO.
Investigating 'ultra-protective' breathing machine settings.
Uses a special chest scan (EIT) to monitor lungs.
Aims to find the safest and most effective breathing machine settings.
Could improve future care for critically ill patients.

Who may be eligible?

This study is looking for adults aged 18 or older who are currently receiving life support (ECMO) for severe lung injury (ARDS). You would also need to be part of a social security scheme, which most people in the UK are through the NHS, and be able to give your informed consent, meaning you understand and agree to take part after discussing it with the medical team.

There are certain reasons why someone wouldn't be able to join. For example, if you are pregnant, or if you have certain medical devices like a pacemaker or an implantable heart defibrillator. We also can't include people who have had recent chest or spinal injuries or surgery, have a collapsed lung that hasn't been fixed, or have certain unstable health conditions requiring a lot of medication to keep your blood pressure steady.

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 on ECMO for severe ARDS?
Do you have a pacemaker or an implantable heart defibrillator? (If yes, you likely can't join.)
Have you had recent chest or spinal trauma/surgery? (If yes, you likely can't join.)
Are you pregnant? (If yes, you cannot join.)

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the medical team will monitor your breathing machine settings using Electrical Impedance Tomography (EIT). This involves placing a special belt around your chest, which is painless and non-invasive. The study will start by recording your current breathing machine settings while on ECMO. Then, your breathing machine's 'tidal volume' (the amount of air given with each breath) will be slowly lowered, step by step, while all other settings are kept the same. After each change, the EIT scan will show how your lungs react, specifically looking at areas that might be collapsing or becoming overstretched. This process will help the doctors find the best tidal volume for your lungs. Additionally, after each step of lowering the tidal volume, doctors will also carefully adjust another breathing machine setting called PEEP (Positive End Expiratory Pressure) to see if it helps keep your lungs open and prevents collapse. The entire monitoring process for each patient will be spread over a period, but the specific duration isn't detailed in this summary. You will be monitored throughout your time on ECMO during these specific assessments.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand the best and safest ways to use breathing machines for patients with severe lung injury, which could improve care for you and others in the future. There are no direct medical risks from the Electrical Impedance Tomography (EIT) itself, as it's a non-invasive monitoring tool. Adjusting ventilator settings is a routine part of critical care, and these adjustments will be made carefully by the medical team based on continuous monitoring. As with any study, you are free to withdraw at any time without affecting your medical care.

Locations (1)

Service de médecine intensive - réanimation Hopital Pitié Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome, which is a severe lung injury where the lungs can't get enough oxygen into the blood.

What is ECMO?

ECMO is a life support machine that takes over the work of the lungs (and sometimes the heart) to give them time to heal.

What is 'ultra-protective ventilation'?

It's a very gentle way of using a breathing machine to support the lungs, using very small breaths to avoid further damage.

What is Electrical Impedance Tomography (EIT)?

EIT is a safe scanning method that uses a special belt around your chest to create a real-time picture of how air moves in and out of your lungs.

Will my breathing machine settings be changed?

Yes, your medical team will carefully and slowly adjust some settings on your breathing machine to see what works best under EIT guidance.

How to find out more

Matthieu Pr SCHMIDT

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.