Clinical Trial TitleA multi-center randomized controlled trial of early use of prone positioning combined with HFNC in COVID-19 induced moderate to severe acute respiratory distress syndrome.
National Clinical Trial Number:NCT04325906
Clinical Trial Protocol Description:
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. 29% of COVID-19 patients may develop acute respiratory distress syndrome (ARDS), in which the primary symptom is hypoxemia that requires oxygen therapy. High-flow nasal cannula (HFNC) has been proved to improve oxygenation and avoid intubation for hypoxemic patients. Previous studies suggest that prone positioning (PP) can increase the average ratio of arterial oxygen tension to the fraction of inspired oxygen (PaO2/FiO2) by +35 mmHg, and reduce mortality in moderate to severe ARDS. Based on the potential beneficial mechanisms of HFNC and PP, we proposed that early use of prone positioning combined with HFNC can improve oxygenation and reduce the need for intubation in COVID-19 induced moderate to severe ARDS patients.
Clinical Trial Eligibility Criteria:
The diagnostic criteria for COVID-19 pneumonia will be based on the CDC guidelines. The diagnosis of ARDS will be assigned to patients who meet the following Berlin definition criteria 15:
- Presence of acute hypoxemic respiratory failure.
- Acute onset within 7 days of insult, or new (within 7 days) or worsening respiratory symptoms.
- Bilateral opacities on chest x-ray or CT not fully explained by effusions, lobar or lung collapse, or nodules.
- Cardiac failure not the primary cause of acute respiratory failure.
- PaO2/FiO2<200mmHg or SpO2/FiO2<240.
This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.