Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The PRONE Study

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Pneumonia, Viral

Intervention / Treatment
-----------------
* Other: Prone Positioning


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control - Usual Care<br>Usual Care | |
| Experimental: Intervention - Prone Positioning<br>Prone Positioning | Other: Prone Positioning<br>* Prone Positioning<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of an escalation in respiratory related care (yes vs no) | 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: intubation any increase in flow of supplemental oxygen transition to high flow nasal cannula increase in fraction of inspired oxygen 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). | During hospitalization, up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation | Oxygen Saturation measured in percent oxygen over a 24-hour period. | Over a consecutive 24-hour period after randomization | 
| Respiratory Effort as assessed by Respiratory Rate | Respiratory effort will be assessed using the respiratory rate (in breaths per minute) over a 24-hour period. | Over a consecutive 24-hour period after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid19, pneumonia, prone positioning, COVID