Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.

Official Title
-----------------
Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study

Conditions
-----------------
ARDS, Covid19, Acute Hypoxemic Respiratory Failure

Intervention / Treatment
-----------------
* Other: Prolonged Proned Positioning
* Other: Traditional Proning Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive COVID test Endotracheal Intubation P:F <150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU. Exclusion Criteria: Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for >48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Experimental: Prolonged Proning Arm<br>Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study | Other: Prolonged Proned Positioning<br>* Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period<br>|
| Active Comparator: Traditional Proning Arm<br>Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study | Other: Traditional Proning Arm<br>* Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration in Prone Position | Time spent in the prone position of hours eligible for prone positioning | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in P:F Ratio | Change in PaO2 on ABG to FiO2 ratio from immediately prior to initiation of prone positioning to end of study period | End of supine session on day 4 | 
| Change in Drive Pressure | Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period | End of supine session on day 4 | 
| Unplanned Extubations | Number of unplanned extubations | End of supine session on day 4 | 
| Pressure Ulcers | Number of patients with pressure ulcers | End of supine session on day 4 | 
| Line Displacement | Number of displaced central venous line or arterial line | End of supine session on day 4 | 
| Vent Free Days | Number of days free from mechanical ventilation | 30 days | 
| Mortality | Mortality at 30 days | 30 days | 
| Rescue Interventions | Patients in which new initiation of inhaled pulmonary vasodilators, ECMO | 96 hours | 
| Tracheostomy | Number of patients who have placement of tracheostomy | 30 days | 
| ICU Free Days | Number of days not in ICU | 30 days | 
| S:F Ratio | Ratio of SpO2 to FiO2 | 96 hours |