Awake Prone Positioning: 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.
Study 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 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Tracheal intubation and/or all-cause death — 28 days Tracheal intubation and/or all-cause death
Trial sites (1)
Facility
City
Region
Status
University Medical Center Hamburg-Eppendorf
Hamburg
Free and Hanseatic City of Hamburg
Recruiting
More Universitätsklinikum Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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