There is one clinical trial.
Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission. The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.
Description: Change in respiratory status will be defined as:1) admission to the ICU and/or a 2) an increase in supplemental oxygen delivery (defined as an increase in oxygen delivery rate of ≥2 liter per minute compared to the oxygen delivery rate at the time of intervention or usual care text message that is sustained for ≥12 or more hours OR the switch to an oxygen delivery method that increases the level of supplemental oxygen.
Measure: Change in respiratory status Time: up to 30 daysDescription: Length of time in the prone position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends in the prone position Time: up to 30 daysDescription: Length of time in the supine/lying on back position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends in the supine position Time: up to 30 daysDescription: Length of time lying on side will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends lying on side Time: up to 30 daysDescription: Length of time sitting up will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends sitting up Time: up to 30 daysDescription: Length of time standing or walking will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends standing or walking Time: up to 30 daysDescription: Dyspnea will be assessed by the modified Borg Dyspnea Score (10-point ordinal scale) from 1= nothing at all to 10= maximal. Higher scores indicate more dyspnea.
Measure: Dyspnea or difficult/labored breathing Time: up to 30 daysDescription: Discomfort with proning (4-point ordinal scale: very comfortable, somewhat comfortable, somewhat uncomfortable, very uncomfortable)
Measure: Discomfort with proning Time: up to 30 daysDescription: Total number of days hospitalized will be abstracted from the electronic medical record.
Measure: Length of hospital stay Time: up to 30 daysDescription: Invasive mechanical ventilation will be abstracted from the electronic medical record.
Measure: Invasive mechanical ventilation Time: up to 30 daysDescription: Loss of IV access as a consequence of turning in bed will be reported by participant using monitoring surveys
Measure: Loss of IV access as a consequence of turning in bed Time: up to 30 daysDescription: ARDS diagnosis will be abstracted from the electronic medical record
Measure: Acute respiratory distress syndrome (ARDS) diagnosis Time: up to 30 daysDescription: Hospital mortality will be abstracted from the electronic medical record
Measure: Hospital mortality Time: up to 30 days