About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Awake Prone Positioning
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Tracheal intubation and/or all-cause death
Tracheal intubation and/or all-cause death
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitätsklinikum Hamburg-Eppendorf
Lead sponsor
Charite University, Berlin, Germany
Collaborator
Asklepios Kliniken Hamburg GmbH
Collaborator
University Hospital Tuebingen
Collaborator
University Hospital Heidelberg
Collaborator
Klinikum Würzburg Mitte gGmbH, Missioklinik
Collaborator
Elisabeth-Krankenhaus Essen
Collaborator
Hannover Medical School
Collaborator
Universitätsklinikum Freiburg
Collaborator
Krankenhaus Barmherzige Brüder, Regensburg
Collaborator
Technical University of Munich
Collaborator
Klinikum Nürnberg
Collaborator
RWTH Aachen University
Collaborator
Lung Clinic Hemer
Collaborator
University of Leipzig
Collaborator
Wuerzburg University Hospital
Collaborator
University Hospital Erlangen
Collaborator
University Hospital Schleswig-Holstein
Collaborator
Klinikum Hanover-Siloah Hospital
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
Bielefeld University
Collaborator