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Article ; Online: Rationale and Design of the Awake Prone Position for Early Hypoxemia in COVID-19 Study Protocol: A Clinical Trial.

Garcia, Michael A / Rampon, Garrett L / Doros, Gheorghe / Jia, Shijing / Jagan, Nikhil / Gillmeyer, Kari / Berical, Andrew / Hudspeth, James / Ieong, Michael / Modzelewski, Katherine L / Schechter-Perkins, Elissa M / Ross, Craig S / Rucci, Justin M / Simpson, Steven / Walkey, Allan J / Bosch, Nicholas A

Annals of the American Thoracic Society

2021  Volume 18, Issue 9, Page(s) 1560–1566

Abstract: ... patients with COVID-19 (APPEX-19 [Awake Prone Position for Early Hypoxemia in COVID-19]). Key innovations ... controlled clinical trial evaluating the safety and effectiveness of awake prone positioning in spontaneously breathing ... disease virulence, and infectivity have created significant barriers to traditional clinical trial practices ...

Abstract The unprecedented public health burdens of coronavirus disease (COVID-19) have intensified the urgency of identifying effective, low-cost treatments that limit the need for advanced life support measures and improve clinical outcomes. However, personal protective equipment and staffing shortages, disease virulence, and infectivity have created significant barriers to traditional clinical trial practices. We present the novel design of a pragmatic, adaptive, multicenter, international, prospective randomized controlled clinical trial evaluating the safety and effectiveness of awake prone positioning in spontaneously breathing patients with COVID-19 (APPEX-19 [Awake Prone Position for Early Hypoxemia in COVID-19]). Key innovations of this trial include
MeSH term(s) Bayes Theorem ; COVID-19 ; Humans ; Hypoxia ; Multicenter Studies as Topic ; Prone Position ; Prospective Studies ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Treatment Outcome ; Wakefulness
Language English
Publishing date 2021-03-01
Publishing country United States
Document type Clinical Trial Protocol ; Journal Article
ZDB-ID 2717461-X
ISSN 2325-6621 ; 1943-5665 ; 2325-6621
ISSN (online) 2325-6621 ; 1943-5665
ISSN 2325-6621
DOI 10.1513/AnnalsATS.202009-1124SD
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