Rationale and design of the Prone Position and Respiratory Outcomes in Non-intubated COVID-19 PatiEnts: The “PRONE” Study

• Published in: Contemporary clinical trials 2021-10, Vol.109, p.106541-106541, Article 106541
• Main Authors: Friedman, Eugene, Franzone, John, Ko, Emily R., Corey, Kristin, Mock, Jason, Alavian, Naseem, Schwartz, Adam, Drummond, M. Bradley, Suber, Tomeka, Linstrum, Kelsey, Bain, William, Castiblanco, Saramaria Afanador, Zak, Martin, Zaeh, Sandra, Gupta, Ishaan, Damarla, Mahendra, Punjabi, Naresh M.
• Format: Article
• Language: English
• Subjects: Awake; COVID-19; Hospitalized; Humans; Multicenter; Patient Positioning; Prone; Prone Position; Randomized; Respiration, Artificial; SARS-CoV-2
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2021.106541

While benefits of prone position in mechanically-ventilated patients have been well-described, a randomized-control trial to determine the effects of prone positioning in awake, spontaneously-breathing patients with an acute pneumonia has not been previously conducted. Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts: the “PRONE” Study (PRONE) was conducted in non-intubated hospitalized patients with coronavirus disease 2019 (COVID-19) pneumonia as defined by respiratory rate ≥ 20/min or an oxyhemoglobin saturation (SpO2) ≤ 93% without supplemental oxygen [1]. The PRONE trial was designed to investigate the effects of prone positioning on need for escalation in respiratory support, as defined by need for transition to a higher acuity level of care, increased fraction of inspired oxygen (FiO2), or the initiation of invasive mechanical ventilation. Secondary objectives were to assess the duration of effect of prone positioning on respiratory parameters such as respiratory rate and SpO2, as well as other outcomes such as time to discharge or transition in level of care. •Randomized multicenter trial of awake prone position in COVID-19•Continuous monitoring of position and respiratory rate