Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study

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.

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