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

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called "awake prone positioning" for patients with acute hypoxic respiratory failure due to pneumonia. This means that patients will be placed on their stomachs while they are awake, which may help improve their breathing and reduce the need for a breathing tube or the risk of death within 28 days. The trial aims to see if this positioning is better than the usual ways of lying down, like on their backs or in a semi-upright position.

To participate in the trial, patients need to be in the intensive care unit and have pneumonia that is causing their breathing difficulties. They should be between the ages of 65 and 74 and showing certain signs of pneumonia, like a cough or changes in their secretions. However, some patients will not be eligible, such as those under 18, pregnant women, or those who are already receiving certain treatments. For those who qualify, the trial will offer a chance to potentially improve their breathing condition through this new approach.

Gender

ALL

Eligibility criteria

• 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