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Recruiting NCT06931938

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

No phase Interventional Acute Hypoxemic Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Awake Prone Positioning.
Who it may be relevant to
Registry conditions: Acute Hypoxemic Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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. The investigators 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.

Detailed 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. The investigators hypothesize 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, the investigators aim to assess safety and tolerability of awake prone positioning in patients with acute hypoxic respiratory failure due to pneumonia on the ICU.

Interventions

  • Other Awake Prone Positioning
    The clinical intervention in the Intervention Group is Awake Prone Positioning, a standard therapy in intensive care units worldwide in ARDS care. The intervention should not be started later than 24 hours after randomization. An earlier start, as soon as possible, after randomization is strongly recommended. In patients in the intervention group standard Awake Prone Positioning for at least 10 hours/day for a length of 72 hours should be applied. The reach the targeted 10 hours / day (per 24 ho

Primary outcome measures

  • Tracheal intubation and/or all-cause death [Time frame: 28 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Medical Center Hamburg-Eppendorf — Hamburg

Identifiers

NCT: NCT06931938 · 2025-101424-BO-ff

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗