RecruitingNAINTERVENTIONAL

Effects on Biotrauma of NMBAs and PP Association During ARDS

This study is investigating how two common treatments, muscle relaxants (called NMBAs) and lying on your front (prone positioning or PP), work together for patients with severe breathing difficulties known as Acute Respiratory Distress Syndrome (ARDS). Doctors often use these treatments together because they believe combining them might protect the lungs from damage more effectively than using them separately. While we know these treatments can help individually, the study aims to see if the combined approach specifically reduces "biotrauma" – a type of lung stress – using a new, reliable blood test. Understanding this will help doctors decide the best way to use these treatments for ARDS patients, as this condition unfortunately still affects many people.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

Start

08 Aug 2024

Estimated completion

01 Dec 2026

Moderate to Severe Acute Respiratory Distress Syndrome

What is this study about?

When people have very serious breathing problems, often called Acute Respiratory Distress Syndrome (ARDS), their lungs can get quite inflamed. Doctors use special breathing machines to help, and over the years, they've learned how to use these machines more gently to protect the lungs. Two other treatments that have shown promise for the sickest patients are giving medicines to relax the muscles (NMBAs) and carefully turning patients to lie on their front, known as prone positioning (PP). These treatments are thought to help by making the pressure inside the lungs more even and reducing harmful stress.

While doctors often use these two techniques together, especially during challenging times like the COVID-19 pandemic, we don't fully understand if combining them offers extra benefits compared to using just one. Both NMBAs and PP are believed to help reduce something called 'biotrauma,' which is damage to the lung tissues. This study wants to find out if using NMBAs and PP together is even better at preventing this damage than using PP alone. To measure this, they'll be using a new, reliable blood test that can show how much stress the lung lining is under.

Ultimately, the goal of this research is to give doctors clearer information so they can make better decisions about how to treat patients with ARDS. This could help improve care and outcomes for people struggling with this serious lung condition. By understanding the combined effects, healthcare professionals can fine-tune their approach to keep patients' lungs as healthy as possible during recovery.

Key takeaways

The study investigates how combining two ARDS treatments affects lung protection.
It aims to see if muscle relaxants + lying on your front reduces lung damage (biotrauma).
A new blood test will be used to measure lung damage.
Findings could help doctors better treat ARDS patients.
This research focuses on moderate to severe ARDS.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and currently receiving help with your breathing through a machine for no more than three days. You must also have been diagnosed with moderate to severe ARDS, which is a serious lung condition, and be covered by social security in the UK or have the right to it. Importantly, a close family member or legal representative must give their written consent for you to take part, as you might be too unwell to do so yourself.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you've already had sessions of lying on your front during your current hospital stay. You also can't have already been given the muscle-relaxing medicines before the study starts. Patients who are already on advanced life support (like ECMO, which is a heart and lung bypass machine) or who have conditions that make prone positioning unsafe, or a history of allergic reactions to muscle relaxants, cannot participate.

Additionally, if you have severe chronic lung problems that require long-term oxygen or a ventilator, or if your overall health is extremely poor (indicated by a high score called SAPS II), you wouldn't be suitable for this study. Patients for whom decisions have been made to limit active treatments would also not be able to join.

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 an adult aged 18 or over?
Have you been on a breathing machine for 3 days or less?
Do you have moderate to severe ARDS?
Have you, or your representative, agreed to give consent for the study?
Are you not pregnant or breastfeeding, and not already on advanced life support systems?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the study will compare two different treatment approaches for a short period while you are in the intensive care unit (ICU). One group will receive muscle relaxant medication (cisatracurium) along with prone positioning (lying on your front), and the other group will receive prone positioning alone. Doctors and nurses will continue to monitor your condition closely, taking blood samples to measure lung damage, and observing how you respond to treatment. The study treatments will only be given for a short time, typically around 48 hours for the muscle relaxants. Otherwise, your medical care will be as normal.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping doctors understand the most effective ways to treat ARDS, which could ultimately improve patient care in the future. There's also a chance that the combined treatment might offer better lung protection for you personally, though this is what the study is trying to confirm. However, there are potential risks associated with any medical treatment, and these will be fully explained by the medical team. Muscle relaxants can have side effects, and prone positioning requires careful management. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Service Médecine Intensive et Réanimation
Verified postcode
Marseille, France· Recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where fluid fills the air sacs in your lungs, making it very difficult to breathe without help.

What are NMBAs?

NMBAs are muscle relaxant medicines. They are sometimes used to help patients on breathing machines, especially when their lungs are very sick.

What is Prone Positioning?

Prone positioning means carefully turning a patient to lie on their stomach. This can help improve breathing and oxygen levels for some patients with severe lung problems.

What is 'biotrauma'?

Biotrauma refers to damage or stress to the lung tissue. This study is looking at ways to reduce this damage to help the lungs heal better.

Will I or my loved one be asleep during the study?

Patients with ARDS, especially those receiving mechanical ventilation and muscle relaxants, are typically sedated (given medicines to keep them asleep) and closely monitored in the intensive care unit.

How to find out more

Sami Hraiech, MD

sami.hraiech@ap-hm.fr 0491964358 Official trial record

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