Covid19, Respiratory Failure
Conditions
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.
Interventions
OTHERUsual Care
No clinical team recommendation, patients will remain in their natural choice of position
OTHERAPPS
Clinical team guidance on prone positioning of patients
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinicians were unblinded to treatment allocation and enrolled patients were considered unblinded. Clinical and safety outcomes were collected from the electronic health record by study investigators blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average S/F ratio | 48 hours from eligibility | Average oxygen saturation to fraction of inspired oxygen ratio |
| Time spent with S/F ratio < 315 | 48 hours from eligibility | Time spent with oxygenation saturation to fraction of inspired oxygen ratio less than 315 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients requiring ICU admission during hospitalization | through study completion, Up to 30 days | Number of patients requiring ICU admission during hospitalization |
| Number of patients experiencing who die prior to discharge | through study completion, Up to 30 days | Number of patients who die prior to hospital discharge |
| Highest oxygen support | 48 hours from eligibility | Highest level of supplemental oxygen required |
| Hospital length of stay | through study completion, Up to 30 days | Number of days from hospital admission to discharge |
| Number of patients requiring intubation | 48 hours From eligibility | Number of patients requiring intubation |
| Number of patients requiring ICU admission during study period | 48 hours from eligibility | Number of patients requiring ICU admission during study period |
Countries
United States
Outcome results
None listed