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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Awake Prone Positioning

    Other intervention

    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.

Treatment groups

342 Participants
are divided into 2 treatment groups
Group A: Awake prone positioningActive comparator 1 intervention
Group B: Standard supine/semi-recumbent positioningNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Tracheal intubation and/or all-cause death

Tracheal intubation and/or all-cause death

Time frame
28 days

Secondary outcomes

Other outcomes

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