RecruitingNAINTERVENTIONAL

Extended Prone Positioning for Intubated ARDS

This study focuses on patients in intensive care with a serious lung condition called Acute Respiratory Distress Syndrome (ARDS), where the lungs struggle to get enough oxygen. Currently, turning patients onto their front (prone position) for about 16-17 hours is a common treatment that helps. This study aims to find out if leaving patients in this tummy-down position for a much longer time – specifically 40 hours – can further improve their chances of survival compared to the standard 16-hour sessions. Researchers believe that longer periods in this position might help the lungs work better and reduce damage from the breathing machine. The main goal is to see if longer prone positioning reduces deaths within 28 days.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

800

Start

18 Oct 2025

Estimated completion

18 Oct 2028

Acute Respiratory Distress Syndrome

What is this study about?

When someone has a very severe lung condition called Acute Respiratory Distress Syndrome (ARDS), their lungs can't get enough oxygen into their blood. This often means they need help breathing with a machine in intensive care. A common and helpful treatment for ARDS is to carefully turn the patient onto their tummy, which is called the 'prone position'. This position can help distribute air more evenly in the lungs and reduce pressure, making it easier for the breathing machine to do its job and potentially lowering the risk of further lung damage.

Previous research has shown that keeping patients in the prone position for around 17 hours at a time can significantly improve their chances of survival. More recently, a study during the COVID-19 pandemic suggested that even longer periods on the tummy – sometimes up to 40 hours – might be even more beneficial. This new study wants to formally test this idea. The main goal is to see if extended periods of prone positioning (40 hours) can lead to more patients surviving compared to the usual 16-hour sessions.

The researchers think that staying in the prone position for longer might give the lungs more time to heal and work better. They also believe that the process of turning patients back onto their backs might undo some of the good effects. By comparing 40-hour sessions to 16-hour sessions, this study hopes to find the best way to use this treatment to improve outcomes for very sick patients in intensive care.

Key takeaways

Study compares 16-hour vs. 40-hour tummy-down (prone) positioning for severe ARDS.
Aims to see if longer periods on the tummy improve survival.
Patients will be in intensive care and on a breathing machine.
No new medications involved; focus is on positioning duration.
Participation is voluntary, and you can withdraw at any time.
Study looks at patient survival and recovery after 28 days.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently in intensive care and need a breathing machine. To be considered, they must have severe Acute Respiratory Distress Syndrome (ARDS) as defined by specific medical guidelines, and their lungs must be struggling significantly to get enough oxygen even with the breathing machine settings optimised. The individual must also have started on the breathing machine within the last 5 days.

There are several reasons why someone might not be able to join the study. For example, if they have already been placed in the prone position during their current intensive care stay or if they are on a very specialised heart-lung bypass machine (ECMO). Other reasons include certain medical conditions like an unstable spine, high pressure in the brain due to injury, or if the medical team believes that turning them onto their tummy would be too risky for their heart and blood pressure.

Additionally, patients would not be included if they are already receiving oxygen at home, if their care is focused only on comfort, or if they are taking part in another study that specifically looks at prone positioning and patient survival. Pregnant individuals, those without insurance, or anyone unable to give their consent (or whose family/proxy refuses) also cannot participate.

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 in intensive care due to very severe breathing problems (ARDS)?
Are you on a breathing machine and started it within the last 5 days?
Do you have stable blood pressure and no specific conditions that would make prone positioning risky?
Have you not already been placed in the prone position during this intensive care stay?
Are you able to give consent, or does your family/proxy agree to your participation?

Answer every question to see your result.

What does participation involve?

If you or your loved one joins this study, you'll be randomly assigned to one of two groups. One group will receive the standard prone positioning, where you'll be carefully turned onto your tummy for 16-hour sessions. The other group will receive extended prone positioning, staying on your tummy for 40-hour sessions. In both groups, there might be a little flexibility to stay in the position for up to 8 extra hours if clinically needed.

Beyond this difference in prone positioning duration, you will continue to receive the best possible intensive care treatment. Medical staff will closely monitor your condition throughout. There are no additional visits required outside of your standard intensive care stay, and the study doesn't involve any new medications. The main focus is on the length of time spent in the prone position. The study will track your progress for 28 days after you're included to see how you're recovering.

Potential risks and benefits

Participating in this study might offer the potential benefit of improved survival or better recovery from severe ARDS, especially if the extended prone positioning proves to be more effective than current standard practice. However, as with any medical treatment, there are potential risks associated with prone positioning, such as skin pressure sores, dislodgement of tubes, or temporary changes in blood pressure. These risks are carefully managed by the intensive care team. Your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting the quality of your medical care.

Locations (1)

Hôpital Saint-Louis
Verified postcode
Paris, France· Recruiting

Common questions

What is ARDS?

ARDS (Acute Respiratory Distress Syndrome) is a severe lung condition where the lungs become inflamed and filled with fluid, making it very hard to breathe and get enough oxygen.

What is 'prone positioning'?

Prone positioning means carefully turning a patient onto their tummy while they are in intensive care. This can help the lungs work better and improve oxygen levels.

How long will patients be on their tummy in this study?

Patients will either be in the prone position for 16 hours (standard group) or 40 hours (extended group) during each session.

Will I take any new medicines in this study?

No, this study does not involve any new medicines. It's focused on the duration of prone positioning.

Can I stop being part of the study once I've joined?

Yes, you or your family can decide to withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Thaïs Walter, Dr

thais.walter@aphp.fr 33. (0)6. 29. 81. 50. 92 Official trial record

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