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

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 1) a novel smartphone-based communication process that facilitates rapid enrollment and intervention delivery while allowing social distancing and conservation of personal protective equipment, 2) Bayesian response-adaptive randomization to allow preferential assignment to the most effective intervention and expedite trial completion compared with frequentist designs, 3) remote electronic collection of patient-reported outcomes and electronic medical record data, and 4) pragmatic prospective use of patient-reported data and data collected as part of routine clinical care. Clinical trial registered with www.clinicaltrials.gov (NCT04344587).

SUBMITTER: Garcia MA

PROVIDER: S-EPMC8489858 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background Infection with SARS-CoV-2 can result in Coronavirus Disease–19 (COVID-19) [1, 2]. While the majority of patients are asymptomatic or have mild disease [3], approximately 14% develop more severe disease including hypoxemic respiratory failure and/or Acute Respiratory Distress Syndrome (ARDS) [3]. Prone positioning is a life-saving intervention for mechanically ventilated patients with moderate-severe ARDS [4]. Based on this, the World Health Organization (WHO) guidelines recommend these patients be considered for a trial of prone positioning [5]. Recently the use of prone positioning in awake non-intubated COVID-19 patients has been recommended by several notable organizations with the goal of preventing intubation and potentially improving patient-oriented outcomes [6, 7]. In contrast to prone positioning for intubated mechanically ventilated patients with ARDS, there have been no randomized control trials examining the role of awake prone positioning for non-intubated patients with hypoxemic respiratory failure. To further explore this question we used rapid review methodology (Tricco et al., 2015 [8]) to quickly identify and synthesize studies examining the effect of awake prone positioning on patients with hypoxemic respiratory failure (including those with ARDS and/or COVID-19). Methods We have elected to use “rapid review” methodology rather than “systematic review” methodology primarily due to the speed and efficiency through which we are able to conduct this review, as previously described [8]. In the absence of an EQUATOR guidance document, we used PRISMA guidelines where applicable [9]. Studies were included if they met the following criteria 1) population – non-intubated patients with hypoxemic respiratory failure, 2) intervention – prone positioning, 3) comparator – usual management, 4) outcomes – intubation, survival, change in respiratory parameters, adverse events, 5) setting – hospitalized patients 6) study design – observational or randomized control trial. Studies were not limited to ARDS or COVID-19 patients. The search strategy was developed by a critical care physician (KP), a critical care epidemiologist (KF) and a medical librarian (NL) (See search details in Online Supplement). Briefly, the search strategy involved combinations of keywords and subject headings relating to the concepts of, 1) SARS-Cov-2 or COVID-19 or coronavirus, 2) awake prone positioning, and 3) hypoxemic respiratory failure, including but not limited to ARDS and other potentially relevant conditions. The search was conducted on May 19, 2020 and was updated on August 7, 2020 with no restrictions on publication language or date. Databases and grey literature sources searched included: MEDLINE (Ovid), PubMed, Trip PRO, Cochrane Library, LitCOVID, WHO COVID-19 Research Database, Centre for Evidence-Based Medicine (CEBM), National Institute for Health and Care Excellence (NICE), medRxiv, BMJ Best Practice, Cambridge Coronavirus Free Access Collection, and Google Scholar. Titles and abstracts were reviewed independently and in duplicate (KP and JW) for selection for full text review. Disagreements were resolved through discussion or with a third reviewer (KS). Full text review and data abstraction was conducted independently and in duplicate (KP, KS, JW). Data abstracted included study characteristics, participant demographics, and outcomes.

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

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