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

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.

SUBMITTER: Friedman E

PROVIDER: S-EPMC8363159 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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

Friedman Eugene E Franzone John J Ko Emily R ER Corey Kristin K Mock Jason J Alavian Naseem N Schwartz Adam A Drummond M Bradley MB Suber Tomeka T Linstrum Kelsey K Bain William W Castiblanco Saramaria Afanador SA Zak Martin M Zaeh Sandra S Gupta Ishaan I Damarla Mahendra M Punjabi Naresh M NM

Contemporary clinical trials 20210813

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 respirator ...[more]

PMID: 34400361

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Project description:BackgroundProne position ventilation (PPV) is resource-intensive, yet the optimal strategy for PPV in intubated patients with COVID-19 is unclear.Research questionDoes a prolonged (24 or more h) PPV strategy improve mortality in intubated COVID-19 patients compared with intermittent (∼16 h with daily supination) PPV?Study design and methodsMulticenter, retrospective cohort study of consecutively admitted intubated COVID-19 patients treated with PPV between March 11 and May 31, 2020. The primary outcome was 30-day all-cause mortality. Secondary outcomes included 90-day all-cause mortality and prone-related complications. Inverse probability treatment weights (IPTW) were used to control for potential treatment selection bias.ResultsOf the COVID-19 patients who received PPV, 157 underwent prolonged and 110 underwent intermittent PPV. Patients undergoing prolonged PPV had reduced 30-day (adjusted hazard ratio [aHR], 0.475; 95% CI, 0.336-0.670; P < .001) and 90-day (aHR, 0.638; 95% CI, 0.461-0.883; P = .006) mortality compared with intermittent PPV. In patients with Pao2/Fio2 ≤ 150 at the time of pronation, prolonged PPV was associated with reduced 30-day (aHR, 0.357; 95% CI, 0.213-0.597; P < .001) and 90-day mortality (aHR, 0.562; 95% CI, 0.357-0.884; P = .008). Patients treated with prolonged PPV underwent fewer pronation and supination events (median, 1; 95% CI, 1-2 vs 3; 95% CI, 1-4; P < .001). PPV strategy was not associated with overall PPV-related complications, although patients receiving prolonged PPV had increased rates of facial edema and lower rates of peri-proning hypotension.InterpretationAmong intubated COVID-19 patients who received PPV, prolonged PPV was associated with reduced mortality. Prolonged PPV was associated with fewer pronation and supination events and a small increase in rates of facial edema. These findings suggest that prolonged PPV is a safe, effective strategy for mortality reduction in intubated COVID-19 patients.

Dataset Information

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

Publications

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

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