Actively Recruiting
Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2026-05-04
342
Participants Needed
1
Research Sites
26 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
Researchers are investigating whether awake prone positioning is better than standard supine or semi-recumbent positioning for patients with acute hypoxemic respiratory failure (AHRF) due to pneumonia. While prone positioning has shown benefits in intubated patients with severe respiratory failure and awake patients with COVID-19 pneumonia, its effects in AHRF patients without COVID-19 remain unclear. This trial aims to determine if awake prone positioning can reduce the need for tracheal intubation or death within 28 days and assess its safety and tolerability in intensive care units. Participants are randomly assigned to one of two groups: the intervention group receives awake prone positioning, which should start within 24 hours after randomization and be applied for at least 10 hours per day over 72 hours. This involves sessions lasting at least 3 hours, with breaks no longer than 2 hours to reach the daily target. The control group receives standard positioning, usually supine or semi-recumbent, without prone positioning. If patients require mechanical ventilation, treatment will follow current ARDS guidelines including prone positioning when appropriate. During the study, participants will be closely monitored for safety and treatment adherence in the intensive care unit. Researchers will track outcomes such as tracheal intubation and all-cause death within 28 days of randomization. The trial will also evaluate the tolerability of awake prone positioning. The total participation timeline includes the initial 72-hour intervention period and follow-up for 28 days to assess the main outcomes and safety measures.
CONDITIONS
Brief Title
Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients in the intensive care unit
- High possibility of pneumonia diagnosed by chest x-ray, CT scan, or clinical signs such as purulent secretions, cough, shortness of breath, or abnormal lung sounds
- Presence of acute hypoxemic respiratory failure with PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315
- Age 18 years or older
You will not qualify if you...
- Age below 18 years
- Pregnant women
- Patients unlikely or unable to comply with awake prone positioning as judged by treating team
- Need for high-flow nasal oxygen, non-invasive ventilation, or CPAP for 4 or more days before enrollment
- Urgent need for endotracheal intubation
- Receiving invasive mechanical ventilation
- Shock requiring high-dose vasopressors
- Participation in another clinical interventional trial within the last 3 months
- Previous participation in the PROSA Trial
- Long-term oxygen therapy or CPAP therapy before hospital admission
- Other treatments as specified in the study manual
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days (72 hours)
Participants are randomly assigned to either Awake Prone Positioning or standard supine/semi-recumbent positioning. Those in the Awake Prone Positioning group receive the intervention starting as soon as possible after randomization, with sessions lasting at least 10 hours per day over a period of 72 hours. Participants in the control group receive standard positioning without awake prone positioning.
Daily visits during treatment period
Trial Site Locations
Total: 1 location
1
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
Research Team
K
Kevin Roedl, MD
D
Dominik Jarczak, MD
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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