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

Eugene Friedman; John Franzone; Emily R Ko; Kristin Corey; Jason Mock; Naseem Alavian; Adam Schwartz; M Bradley Drummond; Tomeka Suber; Kelsey Linstrum; William Bain; Saramaria Afanador Castiblanco; Martin Zak; Sandra Zaeh; Ishaan Gupta; Mahendra Damarla; Naresh M Punjabi

doi:10.1016/j.cct.2021.106541

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

Contemp Clin Trials. 2021 Oct:109:106541. doi: 10.1016/j.cct.2021.106541. Epub 2021 Aug 13.

Authors

Eugene Friedman¹, John Franzone², Emily R Ko², Kristin Corey¹, Jason Mock³, Naseem Alavian³, Adam Schwartz³, M Bradley Drummond³, Tomeka Suber⁴, Kelsey Linstrum⁴, William Bain⁴, Saramaria Afanador Castiblanco⁵, Martin Zak⁵, Sandra Zaeh⁶, Ishaan Gupta⁶, Mahendra Damarla⁷, Naresh M Punjabi⁵

Affiliations

¹ Duke University, Division of Pulmonary, Allergy, and Critical Care Medicine, DUMC Box 102352, Durham, NC 27710, United States of America.
² Duke University, Division of Hospital Medicine, Department of General Internal Medicine, Durham, NC 27710, United States of America.
³ University of North Carolina, Division of Pulmonary Diseases and Critical Care Medicine, Department of Medicine, 130 Mason Farm Road, CB# 7020, 4(th) floor Bioinformatics Bldg, Chapel Hill, NC 27599-7020, United States of America.
⁴ University of Pittsburgh, Division of Pulmonary, Allergy, and Critical Care Medicine, 3459 Fifth Avenue, Montefiore NW628, Pittsburgh, PA 15213, United States of America.
⁵ University of Miami, Division of Pulmonary, Critical Care and Sleep Medicine, University of Miami Miller School Of Medicine, 1951 NW 7th Ave, 2nd Floor, Room 2278, Miami, FL 33136, United States of America.
⁶ Johns Hopkins University, Division of Pulmonary And Critical Care Medicine, 5501 Hopkins Baview Cr., JHAAC, Room 4A.30, Baltimore, MD 21224, United States of America.
⁷ Johns Hopkins University, Division of Pulmonary And Critical Care Medicine, 5501 Hopkins Baview Cr., JHAAC, Room 4A.30, Baltimore, MD 21224, United States of America. Electronic address: mdamarl1@jhmi.edu.

Abstract

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.

Keywords: Awake; COVID-19; Hospitalized; Multicenter; Prone; Randomized.

Publication types

Randomized Controlled Trial

MeSH terms

COVID-19*
Humans
Patient Positioning
Prone Position
Respiration, Artificial
SARS-CoV-2

Abstract

Publication types

MeSH terms

Grants and funding