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NCT Number: NCT06931938

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Awake Prone Positioning

Other

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.

Primary outcomes

  1. Tracheal intubation and/or all-cause death

    Time frame: 28 days

    Tracheal intubation and/or all-cause death

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik Jarczak, MD

CONTACT

[email protected]

+49 40 7410 35315

Kevin Roedl, MD

CONTACT

[email protected]

+49 40 7410 35315

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

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

Registry information

Official study title

Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study

Acronym: PROSA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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