Acute Hypoxemic Respiratory FailurePROSANCT06931938
Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
A study testing Awake Prone Positioning in people with Acute Hypoxemic Respiratory Failure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Conclusive evidence for patients with AHRF without COVID-19 is still missing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Awake Prone Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteGermany
- Study dates
- 11 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Kevin Roedl, MD, +49 40 7410 35315, k.roedl@uke.de
Dominik Jarczak, MD, +49 40 7410 35315, d.jarczak@uke.de
About this study
Official title: Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesis that awake prone position in patients with AHRF is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization.
Read the detailed description
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Since the pandemic the rate of awake prone positioning has increased and became a standard medical therapy in ICUs worldwide. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesize that awake prone position in patients with AHRF is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization. Furthermore, the investigators aim to assess safety and tolerability of awake prone positioning in patients with acute hypoxic respiratory failure due to pneumonia on the ICU.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Awake Prone Positioning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake Prone PositioningOther
The clinical intervention in the Intervention Group is Awake Prone Positioning, a standard therapy in intensive care units worldwide in ARDS care. The intervention should not be started later than 24 hours after randomization. An earlier start, as soon as possible, after randomization is strongly recommended. In patients in the intervention group standard Awake Prone Positioning for at least 10 hours/day for a length of 72 hours should be applied. The reach the targeted 10 hours / day (per 24 hours), it is strongly recommended to use blocks of a longer time period (e.g. multiple 3-5 hours blocks) within the 24h period to reach the anticipated APP goal. It is recommended that the APP therapy within the targeted intervention for 10 hours/day (per 24 h period) is not interrupted for more than 2 hours till reaching the goal of 10 hours / day (per 24 h). It is further strongly recommended that one APP session should last at least 3 hours. (...) For more information please see the protol.
| Study group | Role | What they receive |
|---|---|---|
| Awake prone positioning | Active comparator | The clinical intervention in the Intervention Group is Awake Prone Positioning, a standard therapy in intensive care units worldwide in ARDS care. The intervention should not be started later than 24 hours after randomization. An earlier start, as soon as possible, after randomization is strongly recommended. In patients in the intervention group standard Awake Prone Positioning for at least 10 hours/day for a length of 72 hours should be applied. The reach the targeted 10 hours / day (per 24 hours), it is strongly recommended to use blocks of a longer time period (e.g. multiple 3-5 hours blocks) within the 24h period to reach the anticipated APP goal. It is recommended that the APP therapy within the targeted intervention for 10 hours/day (per 24 h period) is not interrupted for more than 2 hours till reaching the goal of 10 hours/day (per 24h). It is further strongly recommended that one APP session should last at least 3 hours. (...) For more information please see the protocol. Receives: Other: Awake Prone Positioning |
| Standard supine/semi-recumbent positioning | No intervention | Patients randomized to the control arm will receive standard positioning at the discretion of the treating team but excluding APP. Control group patients will remain in their natural choice of position, which is anticipated to favour a supine, semi-recumbent position. The use of awake prone positioning as a so-called rescue intervention is discouraged in the control group and recorded as a protocol violation. If patients have to be tracheal intubated and mechanically ventilated treatment should follow current ARDS guidelines. This includes PP in patients with mild to severe ARDS if PaO2/FiO2 is below 150 mmHg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal intubation and/or all-cause death
Tracheal intubation and/or all-cause death
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start11 Apr 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Asklepios Kliniken Hamburg GmbH, University Hospital Tuebingen, University Hospital Heidelberg, Klinikum Würzburg Mitte gGmbH, Missioklinik, Elisabeth-Krankenhaus Essen, Hannover Medical School, University Hospital Freiburg, Krankenhaus Barmherzige Brüder, Regensburg, Technical University of Munich, Klinikum Nürnberg, RWTH Aachen University, Lung Clinic Hemer, University of Leipzig, Wuerzburg University Hospital, University Hospital Erlangen, University Hospital Schleswig-Holstein, Klinikum Hanover-Siloah Hospital, Ludwig-Maximilians - University of Munich, Bielefeld University
- Responsible party
- Principal investigator, Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Stefan Kluge, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931938
- Sponsor's protocol ID
- 2025-101424-BO-ff
- Other IDs
- 2025
- Acronym
- PROSA
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2025
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymized patient data underlying the results of the publication
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06931938
- Acronym / sponsor ID
- PROSA / 2025-101424-BO-ff
- Conditions
- Acute Hypoxemic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Asklepios Kliniken Hamburg GmbH, University Hospital Tuebingen, University Hospital Heidelberg, Klinikum Würzburg Mitte gGmbH, Missioklinik, Elisabeth-Krankenhaus Essen, Hannover Medical School, University Hospital Freiburg, Krankenhaus Barmherzige Brüder, Regensburg, Technical University of Munich, Klinikum Nürnberg, RWTH Aachen University, Lung Clinic Hemer, University of Leipzig, Wuerzburg University Hospital, University Hospital Erlangen, University Hospital Schleswig-Holstein, Klinikum Hanover-Siloah Hospital, Ludwig-Maximilians - University of Munich, Bielefeld University
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesis that awake prone position in patients with AHRF is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization.
Detailed description
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Since the pandemic the rate of awake prone positioning has increased and became a standard medical therapy in ICUs worldwide. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesize that awake prone position in patients with AHRF is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization. Furthermore, the investigators aim to assess safety and tolerability of awake prone positioning in patients with acute hypoxic respiratory failure due to pneumonia on the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake prone positioning | Active comparator | Other: Awake Prone PositioningThe clinical intervention in the Intervention Group is Awake Prone Positioning, a standard therapy in intensive care units worldwide in ARDS care. The intervention should not be started later than 24 hours after randomization. An earlier start, as soon as possible, after randomization is strongly recommended. In patients in the intervention group standard Awake Prone Positioning for at least 10 hours/day for a length of 72 hours should be applied. The reach the targeted 10 hours / day (per 24 hours), it is strongly recommended to use blocks of a longer time period (e.g. multiple 3-5 hours blocks) within the 24h period to reach the anticipated APP goal. It is recommended that the APP therapy within the targeted intervention for 10 hours/day (per 24 h period) is not interrupted for more than 2 hours till reaching the goal of 10 hours/day (per 24h). It is further strongly recommended that one APP session should last at least 3 hours. (...) For more information please see the protocol. |
| Standard supine/semi-recumbent positioning | No intervention | –Patients randomized to the control arm will receive standard positioning at the discretion of the treating team but excluding APP. Control group patients will remain in their natural choice of position, which is anticipated to favour a supine, semi-recumbent position. The use of awake prone positioning as a so-called rescue intervention is discouraged in the control group and recorded as a protocol violation. If patients have to be tracheal intubated and mechanically ventilated treatment should follow current ARDS guidelines. This includes PP in patients with mild to severe ARDS if PaO2/FiO2 is below 150 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (13 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awake Prone PositioningThe clinical intervention in the Intervention Group is Awake Prone Positioning, a standard therapy in intensive care units worldwide in ARDS care. The intervention should not be started later than 24 hours after randomization. An earlier start, as soon as possible, after randomization is strongly recommended. In patients in the intervention group standard Awake Prone Positioning for at least 10 hours/day for a length of 72 hours should be applied. The reach the targeted 10 hours / day (per 24 hours), it is strongly recommended to use blocks of a longer time period (e.g. multiple 3-5 hours blocks) within the 24h period to reach the anticipated APP goal. It is recommended that the APP therapy within the targeted intervention for 10 hours/day (per 24 h period) is not interrupted for more than 2 hours till reaching the goal of 10 hours / day (per 24 h). It is further strongly recommended that one APP session should last at least 3 hours. (...) For more information please see the protol. | Other | Awake prone positioning |
Primary outcome
Tracheal intubation and/or all-cause death
Time frame: 28 days
Tracheal intubation and/or all-cause death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Individual anonymized patient data underlying the results of the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Kluge, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake Prone Positioning in people with Acute Hypoxemic Respiratory Failure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Roedl, MD (+49 40 7410 35315, k.roedl@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheal intubation and/or all-cause death (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.