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New treatment option for Acute Hypoxemic Respiratory Failure
Official title Awake Prone Positioning in Spontaneous Breathing Patients With Acute Hypoxic Respiratory Failure Due to Pneumonia
ClinicalTrials.gov ID: NCT06931938
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The focus of this trial is to treat patients with respiratory failure. The are selected accordingly. Patients meeting all of the criteria listed...
- 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...
- Appearance of purulent secretions or changes in characteristics (color, odor, quantity, consistency)
- Cough or dyspnea or tachypnea
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- The focus of this trial is to treat patients with respiratory failure. The 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)
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Free and Hanseatic City of Hamburg, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Free and Hanseatic City of Hamburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.