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

Last updated: April 9, 2025
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

Awake Prone Positioning

Clinical Study ID

NCT06931938
2025-101424-BO-ff
  • Ages > 18
  • All Genders

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. We 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 Criteria

Inclusion

Inclusion Criteria:

  • The focus of this trial is to treat patients with respiratory failure. The inclusioncriteria are selected accordingly. Patients meeting all of the criteria listed belowwill be included in the study:

  • Patients in the intensive care unit

  • High possibility of Pneumonia (community-acquired pneumonia orhospital-acquired pneumo-nia) either diagnosed by chest x-ray or computedtomography 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 orSpO2/FiO2 ≤ 315)

Exclusion

Exclusion Criteria:

  • Patients are excluded from the study if any of the following criteria are met atscreening 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 asindicated by the treating team

  • Prolonged need (≥ 4 days) for HFNO, NIV or CPAP before study inclusion

  • Urgent need for endotracheal intubation

  • Invasive Mechanical Ventilation

  • Shocko Defined as need for vasopressor ≥ 0.4 mcg/kg/min to maintain a mean bloodpressure 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

Study Design

Total Participants: 342
Treatment Group(s): 1
Primary Treatment: Awake Prone Positioning
Phase:
Study Start date:
April 08, 2025
Estimated Completion Date:
June 30, 2027

Study Description

Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Since the pandemic the rate of awake prone positioning has increased and became a standard medical therapy in ICUs worldwide. Conclusive evidence for patients with AHRF without COVID-19 is still missing. We 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. Furthermore, we aim to assess safety and tolerability of awake prone positioning in patients with acute hypoxic respiratory failure due to pneumonia on the ICU.

Connect with a study center

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.