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.
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.
Other: Usual Care
No clinical team recommendation, patients will remain in their natural choice of position
Other: APPS
Clinical team guidance on prone positioning of patients
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
Carolinas Medical Center
Charlotte, North Carolina, United States
Stephanie Taylor, MD, Principal Investigator
Wake Forest University Health Sciences