Status:
RECRUITING
Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Charite University, Berlin, Germany
Asklepios Klinikum Harburg
Conditions:
Acute Hypoxemic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Since the pandemic the rate of awak...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT06931938
Start Date
April 11 2025
End Date
June 30 2027
Last Update
August 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246