Using awake prone positioning for patients with acute hypoxic respiratory failure due to pneumonia

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

This study is testing if having patients with pneumonia-related breathing problems lie on their stomachs while awake can help them breathe better and reduce the need for breathing tubes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 342 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Academic / other)
• Locations: 1 site (Hamburg, Free and Hanseatic City of Hamburg)
• Trial ID: NCT06931938 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of awake prone positioning on patients suffering from acute hypoxic respiratory failure (AHRF) due to pneumonia. It aims to determine whether this positioning is more effective than standard supine or semi-recumbent positions in reducing the need for tracheal intubation and all-cause mortality within 28 days. The study will also assess the safety and tolerability of this intervention in an intensive care unit setting. Patients will be monitored closely to evaluate outcomes related to their respiratory function and overall health.

Who should consider this trial

Good fit: Ideal candidates include ICU patients diagnosed with acute hypoxemic respiratory failure due to pneumonia.

Not a fit: Patients under 18 years old, pregnant women, or those unlikely to comply with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the need for intubation and improve survival rates in patients with AHRF due to pneumonia.

How similar studies have performed: Previous studies have shown positive outcomes with awake prone positioning in intubated patients and those with COVID-19 pneumonia, but conclusive evidence for AHRF patients without COVID-19 is still lacking.

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

Where this trial is running

Hamburg, Free and Hanseatic City of Hamburg

• University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)

Study contacts

• Principal investigator: Stefan Kluge, MD — Universitätsklinikum Hamburg-Eppendorf
• Study coordinator: Kevin Roedl, MD

Conditions Acute Hypoxemic Respiratory Failure