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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: k.roedl@uke.de
• Phone: +49 40 7410 35315

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.