Clinical trial NCT04547283: Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19
Official title: Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Respiratory Failure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average S/F ratio
timeFrame: 48 hours from eligibility
measure: Time spent with S/F ratio < 315
timeFrame: 48 hours from eligibility
Secondary outcomes:
measure: Highest oxygen support
timeFrame: 48 hours from eligibility
measure: Number of patients requiring ICU admission during study period
timeFrame: 48 hours from eligibility
measure: Number of patients requiring ICU admission during hospitalization
timeFrame: through study completion, Up to 30 days
measure: Number of patients experiencing who die prior to discharge
timeFrame: through study completion, Up to 30 days
measure: Number of patients requiring intubation
timeFrame: 48 hours From eligibility
measure: Hospital length of stay
timeFrame: through study completion, Up to 30 days
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephanie Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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