NCT06931938 Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
| NCT ID | NCT06931938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 342 participants |
| Start Date | 2025-04-11 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 342 participants in total. It began in 2025-04-11 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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
Contact & Investigator
Stefan Kluge, MD
PRINCIPAL INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Frequently Asked Questions
Who can join the NCT06931938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Hypoxemic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06931938 currently recruiting?
Yes, NCT06931938 is actively recruiting participants. Contact the research team at k.roedl@uke.de for enrollment information.
Where is the NCT06931938 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT06931938 clinical trial?
NCT06931938 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Stefan Kluge, MD at Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 342 participants.