Clinical trial NCT04368000: Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization
Official title: Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
COVID-19
Keywords: COVID-19
Respiratory failure
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 30
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: Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes.

Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for \>12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

Detailed description: In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) is mild in 81% of patients, severe disease occurs in 14%, and 5% of cases result in critical illness. The reported overall case fatality rate (CFR) is 2.3% in China, although the CFR varies widely (0.7- 7.2%) between regions. Older age is associate with increased mortality. The reported CFR is 8% among patients 70-79 years old and 15% in those 80 years and older.

Multiple therapies have been proposed based on in vitro evidence or anecdotal reports. Although, no high quality clinical trials have demonstrated an effective treatment regimen other than supportive care. Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes.

Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for \>12 hours in severe ARDS is strongly recommended by clinical practice guidelines. Improvements in gas exchange, cardiac output, and clearance of secretions have been demonstrated with PP, and are thought to contribute to the survival benefits. Low quality evidence from case series and retrospective studies in awake, spontaneously breathing patients suggest PP is feasible, improves oxygenation, and may avoid the need for mechanical ventilation. A recent prospective observational study of early PP combined with high-flow nasal cannula or non-invasive mechanical ventilation was well tolerated and may help patients avoid intubation.

This study is a single-center non-blinded randomized controlled pragmatic feasibility study comparing the outcomes of prone positioning (intervention) versus usual care (control) in non-intubated patients hospitalized for COVID-19.

Eligibility criteria: Inclusion Criteria:

* Adult (age ≥ 18 years)
* Suspected or Confirmed COVID-19 (Suspected: High clinical suspicion AND pending COVID-19 assay; Confirmed: Positive COVID-19 assay within 10 days)
* Scheduled for admission or already admitted to an inpatient hospital bed
* Patients must be enrolled within 48 hours of hospital admission

Exclusion Criteria:

* Pregnant
* Prisoner
* Contraindication to prone positioning: known increased intracranial pressure \>30 mm Hg or cerebral perfusion pressure \<60 mm Hg, increased abdominal pressure or risk for abdominal compartment syndrome, massive hemoptysis requiring urgent intervention, tracheal surgery or sternotomy during previous 14 days, facial surgery or serious facial trauma within 14 days, pacemaker implantation within 48 hours, unstable spine, femur, or pelvic fractures, chest tube, mean arterial pressure less than 65 mm Hg
* Lung transplant
* Burns on more than 20% of body surface
* Chronic respiratory failure requiring: mechanical ventilation via endotracheal device (e.g. tracheostomy tube, orotracheal tube, or nasotracheal tube)
* Inability to change position from supine to prone and prone to supine without assistance
* Receiving end of life care, comfort measures only, or hospice

Primary outcomes:
measure: Change in imputed partial pressure of oxygen over fraction of inspired oxygen (PaO2/FiO2) from peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
timeFrame: 72 hours
Secondary outcomes:
measure: Change in imputed PaO2/FiO2 from SpO2/FiO2
timeFrame: 48 hours
measure: Proportion of participants requiring endotracheal intubation
timeFrame: Up to 8 weeks
measure: Proportion of participants requiring mechanical ventilation
timeFrame: Up to 8 weeks
measure: Proportion of participants transferred to intensive care for worsening respiratory failure
timeFrame: Up to 8 weeks
measure: Proportion of participants who had escalated oxygen delivery needs
timeFrame: Up to 8 weeks
measure: Average number of days hospitalized
timeFrame: Up to 8 weeks
measure: Average number of ventilator-free days
timeFrame: Up to 8 weeks
measure: Proportion of participants discharged from hospital on hospice
timeFrame: Up to 8 weeks
measure: Proportion of participants with all-cause inpatient mortality
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Stacy A Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: