Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
This study aims to determine if a strategy of recommending prone (on stomach) positioning of patients positive or suspected positive for coronavirus disease 2019 (COVID-19) requiring supplemental oxygen, but not mechanically ventilated, Is feasible in the inpatient setting. This study will be performed as a pragmatic pilot clinical trial to gain information relevant to the future conduct of a larger trial.

Detailed Description
-----------------
Severe acute respiratory syndrome coronavirus-2, SARS-CoV-2, the virus causing coronavirus disease 2019 (COVID-19) pandemic, has rapidly led to significant morbidity and mortality worldwide, primarily through lower respiratory tract involvement progressing from hypoxemia to acute respiratory distress syndrome. Novel approaches to improving oxygenation are urgently needed to limit aerosolization concerns and resource scarcity associated with intubation and, to a lesser extent, other forms of advanced respiratory support. Prone positioning in mechanically ventilated patients with hypoxemic respiratory failure has been associated with improvement in oxygenation and mortality in patients with acute respiratory distress syndrome (ARDS). The prone position appears to provide more uniform lung perfusion, shifting ventilation to well-perfused lung segments and recruitment of dependent atelectatic regions of lung. Physiological alterations associated with the prone position would foreseeably also apply to spontaneously breathing patients and evidence from small observational studies suggests that prone positioning in non-intubated patients is feasible associated with improvement in oxygenation. However, it remains unknown if a prone ventilation strategy is truly beneficial for non-intubated hypoxic Covid-19 patients, and this question has stimulated interest in the conduct of rigorous randomized controlled trials (RCT). However, the awake prone strategy is a complex medical intervention with multiple implementation nuances such as adoption, feasibility, and tolerability that may affect successful conduct of a definitive RCT. In order to increase the likelihood of a successful future RCT, the investigators will conduct the APPS pilot study. The overall aim of the APPS pilot trial was to assess feasibility and important contextual factors for a large RCT to compare the clinical effectiveness of an Awake-Prone Positioning Strategy (APPS) for respiratory support versus usual care alone for hypoxic adults with Covid-19.

Official Title
-----------------
Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19: A Pilot Randomized Controlled Trial

Conditions
-----------------
Covid19, Respiratory Failure

Intervention / Treatment
-----------------
* Other: Usual Care
* Other: APPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized patients with positive COVID testing during hospitalization or 7 days prior OR Hospitalized with suspected COVID pneumonia room air oxygen saturation <93% or oxygen requirement > or equal to 3 Liters per minute Exclusion Criteria: unable to turn self, spinal instability, facial or pelvic fractures, open chest or open abdomen, altered mental status, anticipated difficult airway, show signs of respiratory fatigue, or receiving end-of-life care

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Participants randomized to this arm will remain in their clinician's team standard practice and their natural choice of position, which is anticipated to favor a supine (rather than prone) position. | Other: Usual Care<br>* No clinical team recommendation, patients will remain in their natural choice of position<br>|
| Experimental: Awake-Prone Positioning Strategy<br>Participants randomized to this arm will receive guidance from their Inpatient treatment team to assume the prone position for as much time as is tolerable during hospitalization. | Other: APPS<br>* Clinical team guidance on prone positioning of patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average S/F ratio | Average oxygen saturation to fraction of inspired oxygen ratio | 48 hours from eligibility | 
| Time spent with S/F ratio < 315 | Time spent with oxygenation saturation to fraction of inspired oxygen ratio less than 315 | 48 hours from eligibility | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest oxygen support | Highest level of supplemental oxygen required | 48 hours from eligibility | 
| Number of patients requiring ICU admission during study period | Number of patients requiring ICU admission during study period | 48 hours from eligibility | 
| Number of patients requiring ICU admission during hospitalization | Number of patients requiring ICU admission during hospitalization | through study completion, Up to 30 days | 
| Number of patients experiencing who die prior to discharge | Number of patients who die prior to hospital discharge | through study completion, Up to 30 days | 
| Number of patients requiring intubation | Number of patients requiring intubation | 48 hours From eligibility | 
| Hospital length of stay | Number of days from hospital admission to discharge | through study completion, Up to 30 days |