Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
Recruiting now · Not applicable
Conditions studied: Acute Hypoxemic Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT06931938
- Run by
- Universitätsklinikum Hamburg-Eppendorf
- People needed
- 342
- Starts
- 2025-04-11
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The focus of this trial is to treat patients with respiratory failure. The inclusion criteria are selected accordingly. Patients meeting all of the criteria listed below will be included in the study:
- 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
- Evocative auscultation
- Presence of acute hypoxemic respiratory failure (PaO2/FIO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315)
You may not qualify if…
- Patients are excluded from the study if any of the following criteria are met at screening or before ran-domization, a detailed list is shown in the study manual:
- 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
- Urgent need for endotracheal intubation
- Invasive Mechanical Ventilation
- Shock
- o Defined as need for vasopressor ≥ 0.4 mcg/kg/min to maintain a mean blood pressure of ≥ 65 mmHg or systolic blood pressure ≥ 90 mmHg
- Participation in another clinical interventional trial in the last 3 months
- Previous Participation in the PROSA Trial
- Long-term oxygenation therapy (LTOT) or continuous positive airway pressure (CPAP) therapy before hospital admission
- Treatment
Where it is running
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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