Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06931938

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

Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2026-05-04

342

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

Sponsors

U

Universitätsklinikum Hamburg-Eppendorf

Lead Sponsor

C

Charite University, Berlin, Germany

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is in the intensive care unit
  • High likelihood of pneumonia diagnosed by chest x-ray, CT scan, or clinical signs such as purulent secretions, cough, difficulty breathing, or abnormal lung sounds
  • Presence of acute hypoxemic respiratory failure defined by PaO2/FiO2 64 300 mmHg or SpO2/FiO2 64 315
Not Eligible

You will not qualify if you...

  • Age below 18 years
  • Pregnant women
  • Unable or unlikely to comply with awake prone positioning as judged by the treating team
  • Need for high-flow nasal oxygen, non-invasive ventilation, or continuous positive airway pressure for 4 or more days before study inclusion
  • Urgent need for endotracheal intubation
  • Currently on invasive mechanical ventilation
  • Shock requiring vasopressors at or above 0.4 mcg/kg/min to maintain blood pressure
  • Participation in another interventional clinical trial within the last 3 months
  • Previous participation in the PROSA trial
  • Long-term oxygen therapy or continuous positive airway pressure therapy before hospital admission
  • Other ongoing treatments as specified in the study manual

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Medical Center Hamburg-Eppendorf

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

Actively Recruiting

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Research Team

K

Kevin Roedl, MD

CONTACT

D

Dominik Jarczak, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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