Status:
TERMINATED
Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization
Lead Sponsor:
University of Utah
Conditions:
Respiratory Failure
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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 ons...
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 11...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04368000
Start Date
April 29 2020
End Date
August 6 2020
Last Update
December 3 2020
Active Locations (1)
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1
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132