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

NCT06931938 | Recruiting

• 1 other identifier: 2025-101424-BO-ff
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Tracheal intubation and/or all-cause death

  Tracheal intubation and/or all-cause death

  28 days

Study Arms (2)

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.

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.

Interventions

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.

Awake prone positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center Hamburg-Eppendorf

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

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Stefan Kluge, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Roedl, MD

CONTACT

+49 40 7410 35315; k.roedl@uke.de

Dominik Jarczak, MD

CONTACT

+49 40 7410 35315; d.jarczak@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 17, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: up to 36 Months after publication of results
• Access Criteria: Upon resonable request

Locations

DE (1)