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.

Autor:	Gupta L; Anesthesiology and Critical Care Medicine, Maulana Azad Medical College, New Delhi, IND., Bassi A; Public Health, The George Institute for Global Health, New Delhi, IND., Tirupakuzhi Vijayaraghavan BK; Critical Care Medicine, Apollo Hospitals, Chennai, IND., Bains L; Surgery, Maulana Azad Medical College, New Delhi, IND.; Surgery, Lok Nayak Hospital, New Delhi, IND., Saxena KN; Anesthesiology, Maulana Azad Medical College, New Delhi, IND.; Anesthesiology, Lok Nayak Hospital, New Delhi, IND., Hammond NE; Critical Care Medicine, The George Institute for Global Health, Sydney, AUS.; Medicine, University of New South Wales, Sydney, AUS.; Intensive Care Unit, Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, AUS., Myatra S; Anesthesiology and Critical Care Medicine, Tata Memorial Hospital, Mumbai, IND., Divatia J; Critical Care Medicine, Tata Memorial Hospital, Mumbai, IND., Rajagopal S; Critical Care Medicine, Apollo Hospitals, Chennai, IND., Tanna GLD; Health Economics and Medical Statistics, The George Institute for Global Health, Sydney, AUS., Liu X; Epidemiology and Biostatistics, The George Institute for Global Health, Sydney, AUS.; Medicine, University of New South Wales, Sydney, AUS., Knowles S; Critical Care Medicine, The George Institute for Global Health, Sydney, AUS., Bathla N; Public Health, The George Institute for Global Health, New Delhi, IND., Jha V; Administration, The George Institute for Global Health, New Delhi, IND.; Medicine, University of New South Wales, Sydney, AUS.; Medicine, Imperial College London, London, GBR., Venkatesh B; Critical Care Medicine, The George Institute for Global Health, Sydney, AUS.; Critical Care Medicine, The George Institute for Global Health, New Delhi, IND.; Intensive Care Medicine, Princess Alexandra Hospital, Auchenflower, AUS.; Intensive Care Medicine, University of Queensland, Brisbane, AUS.; Intensive Care Medicine, The Wesley Hospital, Auchenflower, AUS.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Oct 11; Vol. 16 (10), pp. e71267. Date of Electronic Publication: 2024 Oct 11 (Print Publication: 2024).
DOI:	10.7759/cureus.71267
Abstrakt:	Background: During 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. Methods: We 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. Results: Between 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). Conclusions: The 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. Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. The George Institute for Global Health Institutional Ethics Committee issued approval 15/2020. The study was registered in April 2021 with the Clinical Trial Registry - India (CTRI registration number: CTRI/2021/04/0331750). Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: The trial was supported by internal research funds from The George Institute for Global Health. The masks used in the intervention arm of the trial were supplied by Materialise, Belgium. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, Gupta et al.)
Databáze:	MEDLINE
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