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Awake Prone Positioning Strategy for Nonintubated Hypoxic Patients with COVID-19: A Pilot Trial with Embedded Implementation Evaluation.
Taylor, Stephanie Parks; Bundy, Henry; Smith, William M; Skavroneck, Sara; Taylor, Brice; Kowalkowski, Marc A.
  • Taylor SP; Department of Internal Medicine and.
  • Bundy H; Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, North Carolina.
  • Smith WM; Department of Internal Medicine and.
  • Skavroneck S; Department of Internal Medicine and.
  • Taylor B; Department of Internal Medicine and.
  • Kowalkowski MA; Division of Pulmonary and Critical Care, Atrium Health's Carolinas Medical Center, Charlotte, North Carolina; and.
Ann Am Thorac Soc ; 18(8): 1360-1368, 2021 08.
Article in English | MEDLINE | ID: covidwho-1334791
ABSTRACT
Rationale Prone positioning is an appealing therapeutic strategy for nonintubated hypoxic patients with coronavirus disease (COVID-19), but its effectiveness remains to be established in randomized controlled trials.

Objectives:

To identify contextual factors relevant to the conduct of a definitive clinical trial evaluating a prone positioning strategy for nonintubated hypoxic patients with COVID-19.

Methods:

We conducted a cluster randomized pilot trial at a quaternary care teaching hospital. Five inpatient medical service teams were randomly allocated to two treatment arms 1) usual care (UC), consisting of current, standard management of hypoxia and COVID-19; or 2) the Awake Prone Positioning Strategy (APPS) plus UC. Included patients had positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing or suspected COVID-19 pneumonia and oxygen saturation less than 93% or new oxygen requirement of 3 L per minute or greater and no contraindications to prone positioning. Oxygenation measures were collected within 48 hours of eligibility and included nadir oxygen saturation to fraction of inspired oxygen (S/F) ratio and time spent with S/F ratio less than 315. Concurrently, we conducted an embedded implementation evaluation using semistructured interviews with clinician and patient participants to determine contextual factors relevant to the successful conduct of a future clinical trial. The primary outcomes were drawn from an implementation science framework including acceptability, adoption, appropriateness, effectiveness, equity, feasibility, fidelity, and penetration.

Results:

Forty patients were included in the cluster randomized trial. Patients in the UC group (n = 13) had a median nadir S/F ratio over the 48-hour study period of 216 (95% confidence interval [95% CI], 95-303) versus 253 (95% CI, 197-267) in the APPS group (n = 27). Patients in the UC group spent 42 hours (95% CI, 13-47) of the 48-hour study period with an S/F ratio below 315 versus 20 hours (95% CI, 6-39) for patients in the APPS group. Mixed-methods analyses uncovered several barriers relevant to the conduct of a successful definitive randomized controlled trial, including low adherence to prone positioning, large differences between physician-recommended and patient-tolerated prone durations, and diffusion of prone positioning into usual care.

Conclusions:

A definitive trial evaluating the effect of prone positioning in nonintubated patients with COVID-19 is warranted, but several barriers must be addressed to ensure that the results of such a trial are informative and readily translated into practice.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Wakefulness / COVID-19 Type of study: Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: Ann Am Thorac Soc Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Wakefulness / COVID-19 Type of study: Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: Ann Am Thorac Soc Year: 2021 Document Type: Article