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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Other: Awake Prone Positioning

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 Type: Interventional
• Enrollment (Estimated): 342
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Roedl, MD; Phone Number: +49 40 7410 35315; Email: k.roedl@uke.de
• Study Contact Backup: Name: Dominik Jarczak, MD; Phone Number: +49 40 7410 35315; Email: d.jarczak@uke.de

Study Locations

• Germany
  • Free and Hanseatic City of Hamburg
    • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
      • Recruiting
      • University Medical Center Hamburg-Eppendorf
      • Contact: Kevin Roedl, MD; Phone Number: +49 40 7410 35315; Email: k.roedl@uke.de
      • Contact: Dominik Jarczak, MD; Phone Number: +49 40 7410 35315; Email: d.jarczak@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Awake prone positioning; 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.	Other: Awake Prone Positioning; 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.
No Intervention: Standard supine/semi-recumbent positioning; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal intubation and/or all-cause death	Tracheal intubation and/or all-cause death	28 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Charite University, Berlin, Germany; Hannover Medical School; RWTH Aachen University; Ludwig-Maximilians - University of Munich; University of Leipzig; University Hospital Heidelberg; University Hospital Tuebingen; Technical University of Munich; University Hospital Schleswig-Holstein; Wuerzburg University Hospital; Universitätsklinikum Freiburg; Asklepios Kliniken Hamburg GmbH; University Hospital Erlangen; Klinikum Nürnberg; Krankenhaus Barmherzige Brüder, Regensburg; Bielefeld University; Lung Clinic Hemer; Elisabeth-Krankenhaus Essen; Klinikum Hanover-Siloah Hospital; Klinikum Würzburg Mitte gGmbH, Missioklinik
• Investigators: Principal Investigator: Stefan Kluge, MD, Universitatsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2025-101424-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual anonymized patient data underlying the results of the publication
• IPD Sharing Time Frame: up to 36 Months after publication of results
• IPD Sharing Access Criteria: Upon resonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No