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

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

Interventions

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.

Sponsors & Collaborators

• Charite University, Berlin, Germany

  collaborator OTHER

• Asklepios Kliniken Hamburg GmbH

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Klinikum Würzburg Mitte gGmbH, Missioklinik

  collaborator UNKNOWN

• Elisabeth-Krankenhaus Essen

  collaborator UNKNOWN

• Hannover Medical School

  collaborator OTHER

• Universitätsklinikum Freiburg

  collaborator UNKNOWN

• Krankenhaus Barmherzige Brüder, Regensburg

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Klinikum Nürnberg

  collaborator OTHER

• RWTH Aachen University

  collaborator OTHER

• Lung Clinic Hemer

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• University Hospital Erlangen

  collaborator OTHER

• University Hospital Schleswig-Holstein

  collaborator OTHER

• Klinikum Hanover-Siloah Hospital

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Bielefeld University

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Stefan Kluge, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-11

Primary Completion

2026-12-30

Completion

2027-06-30

Countries

• Germany

Study Locations