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Simple Face-Down position could save lives in breathing failure

NCT ID NCT06931938

Disease control Sponsor: Universitätsklinikum Hamburg-Eppendorf Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether awake patients with acute breathing failure who lie face down (prone positioning) for at least 10 hours a day for 3 days are less likely to need a breathing tube or die within 28 days, compared to standard care. The trial will include 342 intensive care unit patients with pneumonia-related breathing failure in Germany. The goal is to see if this simple, low-cost technique can improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Awake prone positioning (lying face down while awake)
What this could lead to
If it works, this could provide a simple, low-cost way to help patients with respiratory failure avoid needing a breathing tube and reduce the risk of death.
What could go wrong
This is a relatively early study (Phase NA) and previous evidence is mostly from COVID-19 patients. It may not work for other causes of respiratory failure, and lying face down can be uncomfortable or difficult for some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 342 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The focus of this trial is to treat patients with respiratory failure. The inclusion criteria are selected accordingly. Patients meeting all of the criteria listed below will be included in the study: * Patients in the intensive care unit * High possibility of Pneumonia (community-acquired pneumonia or hospital-acquired pneumo-nia) either diagnosed by chest x-ray or computed tomography or clinically diagnosed at least with one of the following signs * Appearance of purulent secretions or changes in characteristics (color, odor, quantity, consistency) * Cough or dyspnea or tachypnea * Evocative auscultation * Presence of acute hypoxemic respiratory failure (PaO2/FIO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315) Exclusion Criteria: * Patients are excluded from the study if any of the following criteria are met at screening or before ran-domization, a detailed list is shown in the study manual: * Age below 18 * Pregnant woman * Patient is unlikely/unable to awake prone positioning, or to be compliant as indicated by the treating team * Prolonged need (≥ 4 days) for HFNO, NIV or CPAP before study inclusion * Urgent need for endotracheal intubation * Invasive Mechanical Ventilation * Shock o Defined as need for vasopressor ≥ 0.4 mcg/kg/min to maintain a mean blood pressure of ≥ 65 mmHg or systolic blood pressure ≥ 90 mmHg * Participation in another clinical interventional trial in the last 3 months * Previous Participation in the PROSA Trial * Long-term oxygenation therapy (LTOT) or continuous positive airway pressure (CPAP) therapy before hospital admission * Treatment

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Conditions

The condition(s) this trial relates to.

acute respiratory failure pneumonia respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute hypoxemic respiratory failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

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