Covid19, Pneumonia, Viral
Conditions
Keywords
covid19, pneumonia, prone positioning, COVID
Brief summary
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.
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.
Interventions
OTHERProne Positioning
Prone Positioning
Sponsors
Duke University
University of North Carolina
University of Miami
University of Pittsburgh
Smith & Nephew, Inc.
Nox Medical Iceland
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of an escalation in respiratory related care (yes vs no) | During hospitalization, up to 30 days | Participants will be assessed for the occurrence of an escalation in respiratory related care (Yes or No). Escalation in respiratory related care is clinically defined as any of the following: 1. intubation 2. any increase in flow of supplemental oxygen 3. transition to high flow nasal cannula 4. increase in fraction of inspired oxygen 5. transfer from a lower to a higher level acuity of care (e.g. medical floor to intermediate care unit (IMC) or intensive care unit (ICU); IMC to ICU). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation | Over a consecutive 24-hour period after randomization | Oxygen Saturation measured in percent oxygen over a 24-hour period. |
| Respiratory Effort as assessed by Respiratory Rate | Over a consecutive 24-hour period after randomization | Respiratory effort will be assessed using the respiratory rate (in breaths per minute) over a 24-hour period. |
Countries
United States
Outcome results
None listed