ArticleCureus2024
Pilot Randomized Clinical Trial of a Passive Non-invasive Positive End-Expiratory Pressure (PEEP) Device for Delivering Positive Pressure Therapy Compared to Standard Care in Non-critically Ill Patients With COVID-19.
Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
15 authors.
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Abstract
backgroundDuring the COVID-19 pandemic, there were reports of a shortage of ventilators and oxygen supply, particularly in resource-limited settings. We report the preliminary evaluation of a non-invasive positive end-expiratory pressure (PEEP) mask in hospitalized non-critically ill patients with COVID-19.
methodsWe randomly assigned hospitalized adult patients with confirmed COVID-19 infection and requiring greater than 40% supplemental oxygen to either standard care oxygen delivery (control) or via Materialise passive non-invasive PEEP device mask (intervention; Belgium). The primary outcome was a change in mean respiratory rate from baseline over the first three hours after the commencement of the intervention. Secondary outcomes included dyspnea score, need for escalation of respiratory or cardiovascular support, days alive and free of ICU, and day-28 mortality.
resultsBetween April 30, 2021, and October 10, 2021, we enrolled 132 (65 control, 67 intervention) patients in the study. The mean respiratory rates at baseline were 23 ± 3 and 23 ± 3 in the control and intervention groups, with no significant differences at three hours (23 ± 2.3 vs. 23 ± 2.1, p=0.14). The control group had a higher mean dyspnea score compared to the intervention group (day 5: 5.4 ± 1.6 vs. 4.7 ± 1.4, p=0.015; day 6: 4.7 ± 1.7 vs. 4.0 ± 0.7, p=0.008). A higher proportion of patients in the control group required escalation of respiratory support (38%), as compared to intervention (12%) (p=0.0004). The two groups had no significant differences across other secondary outcomes or with respect to adverse events (barotrauma, aspiration pneumonia, need for vasopressor support).
conclusionsThe use of the novel mask compared to standard care in hospitalized non-critically ill patients with COVID-19 was not associated with reductions in the respiratory rate but was associated with a reduction in the need for escalation of respiratory support without an increase in adverse effects. Large-scale clinical trials of this device are warranted.
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