Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
Purpose
The overall objective of this study is to determine whether a positional maneuver (e.g., prone positioning) decreases the need for escalation of respiratory-related care in patients with coronavirus (COVID-19) pneumonia.
Conditions
- Covid19
- Pneumonia, Viral
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years - COVID-19 positive by nasopharyngeal swab or serostatus - Use of supplemental oxygen OR respiratory rate ≥ 20
Exclusion Criteria
- BMI ≥ 45 kg/m2 - Pregnancy - Chest tube placement - Hemodynamic instability with mean arterial pressure < 60 mmHg - Thoracic or abdominal wounds - Chest wall deformities - Vertebral column deformities that would preclude prone positioning - Facial trauma or surgery in the last 30 days - Established diagnosis of interstitial lung disease - Prior single or double lung transplant - Surgery for spine, femur, or pelvis in the last 3 months - Thoracic or cardiac surgery in the last 30 days - Pacemaker placement last 7 days
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Control - Usual Care |
Usual Care |
|
|
Experimental Intervention - Prone Positioning |
Prone Positioning |
|
Recruiting Locations
More Details
- NCT ID
- NCT04517123
- Status
- Completed
- Sponsor
- Johns Hopkins University
Detailed Description
As the initial outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19) has spread beyond Wuhan, China it has become a pandemic affecting over 178 countries. Of patients admitted to the ICU, upwards of 85% developed the acute respiratory distress syndrome (ARDS) and most if not all required mechanical ventilation. The beneficial effects of prone positioning for ARDS have been well described. Coupling the reported benefits of prone positioning in COVID-19 associated ARDS patients with the known beneficial effects of early prone-positioning in the treatment of ARDS, it is not surprising that many hospital systems are advocating prone positioning for treatment of ARDS in patients with COVID-19. However, as the pandemic continues to progress in the United States and the number of new cases grows as new clusters emerge, the possibility of 'rationing' ventilators becomes more real. Therefore, therapies that prevent the need for mechanical ventilation are desperately needed. Given the distinct benefit that patients with COVID-19 have with prone positioning, the overarching hypothesis of this trial is that patients with high risk for respiratory failure may also benefit from prone positioning.