RecruitingNAINTERVENTIONAL

Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia

This study is investigating if a technique called 'awake prone positioning' can help adults who have severe breathing difficulties because of pneumonia. Awake prone positioning means lying on your front while awake. Doctors already know this method can help patients on breathing machines and those with COVID-19 pneumonia. However, it's not known if it helps people with similar breathing problems not caused by COVID-19. The main goal is to find out if lying on your front can lower the chance of needing a breathing tube (intubation) or dying within 28 days compared to lying on your back or side. The study will also check how safe and comfortable this position is for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

342

Start

11 Apr 2025

Estimated completion

30 Jun 2027

Acute Hypoxemic Respiratory Failure

What is this study about?

This study is designed to explore a specific way of helping patients who have very serious breathing problems caused by pneumonia. This condition is known as 'acute hypoxemic respiratory failure.' When you have this, your lungs struggle to get enough oxygen into your blood, making it hard to breathe.

The technique we're looking at is called 'awake prone positioning.' This simply means lying on your stomach while you are awake and not on a breathing machine. Doctors have found that lying on your front can be really helpful for people who are very ill with breathing difficulties and are on a ventilator. It also showed good results for patients with COVID-19 pneumonia who were awake.

However, we don't yet have strong evidence to show if this method works for patients with similar breathing problems but who don't have COVID-19. The aim of this study is to see if lying on your front can reduce the need for a breathing tube (tracheal intubation) or lower the risk of dying within 28 days after starting the treatment, compared to staying on your back or side. We also want to understand if this position is safe and comfortable for patients in an intensive care unit (ICU).

Key takeaways

New study to see if lying on your front (awake prone positioning) helps adults with severe pneumonia breathing problems.
Aims to reduce the need for a breathing tube or lower the risk of death.
Focuses on patients not needing a breathing machine yet, and without COVID-19.
Will assess how safe and comfortable this position is.
Taking part means being in the intensive care unit and being monitored for at least 28 days.

Who may be eligible?

To be part of this study, you would need to be an adult in the intensive care unit suffering from severe breathing problems due to pneumonia. Your pneumonia would either be confirmed by scans like X-rays or CT scans, or it would be strongly suspected based on symptoms like changes in cough, shortness of breath, or findings from listening to your chest.

You would not be able to join the study if you are under 18 or pregnant. Also, if you already need a breathing tube urgently, are already on a breathing machine, or have been on other types of breathing support (like certain masks) for a long time before the study, you wouldn't be eligible. Patients in shock (a serious condition where your body isn't getting enough blood flow) or those already in another clinical trial would also be excluded.

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 (18 years or older)?
Are you currently in an intensive care unit (ICU)?
Do you have severe breathing problems due to pneumonia?
Are you not currently on a breathing machine (ventilator)?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

This description doesn't provide fine details on what participation involves, such as specific visits, medications, or duration beyond 28 days. However, if you are eligible and agree to take part, you would be randomly assigned to either lie on your front (awake prone positioning) or stay in the standard position (on your back or side). The medical team would carefully monitor your breathing and overall health in the intensive care unit for at least 28 days. The main measurements would be whether you need a breathing tube or if you unfortunately pass away within that 28-day period. The study would also observe how comfortable you are and if there are any side effects from lying on your front.

Potential risks and benefits

The potential benefit of taking part is that lying on your front might improve your breathing and reduce your chance of needing a breathing tube or even save your life. However, lying on your front might be uncomfortable for some, and there could be a small risk of skin sores or other issues, although the medical team would monitor you closely. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is 'awake prone positioning'?

It means lying on your stomach (front) while you are awake, to help improve your breathing.

Who is this study for?

It's for adults in intensive care with serious breathing problems from pneumonia, who are not on a breathing machine.

Why is lying on your front helpful for breathing?

It can help your lungs work better by allowing more oxygen into your blood, especially if you have lung problems.

What will happen if I take part?

You'd either be asked to lie on your front or stay in a standard position, and doctors would watch your breathing very closely for at least 28 days.

Can I stop participating if I want to?

Yes, absolutely. You can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Kevin Roedl, MD

k.roedl@uke.de +49 40 7410 35315 Official trial record

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