Official Title
Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
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.

Completed
COVID19
Pneumonia, Viral

Other: Prone Positioning

Prone Positioning

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Johns Hopkins Univeristy
Baltimore, Maryland, United States

University of North Carolina
Chapel Hill, North Carolina, United States

Duke University
Durham, North Carolina, United States

UPMC
Pittsburgh, Pennsylvania, United States

Naresh Punjabi, MD, Principal Investigator
Johns Hopkins University

Johns Hopkins University
NCT Number
Keywords
COVID19
Pneumonia
Prone positioning
Covid
MeSH Terms
COVID-19
Pneumonia
Pneumonia, Viral