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. 2022 Jul 8;12(7):e060320.
doi: 10.1136/bmjopen-2021-060320.

Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol

Mai-Anh Nay  1 , Benjamin Planquette  2   3 , Christophe Perrin  4 , Jérémy Clément  5 , Laurent Plantier  6   7 , Aymeric Sève  8 , Sylvie Druelle  9 , Marine Morrier  10 , Jean-Baptiste Lainé  11 , Léa Colombain  12 , Grégory Corvaisier  13 , Nicolas Bizien  14 , Xavier Pouget-Abadie  15 , Adrien Bigot  16 , Louis Bernard  7   17 , Elsa Nyamankolly  18 , Guillaume Fossat  19 , Thierry Boulain  19
Affiliations

Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol

Mai-Anh Nay et al. BMJ Open. .

Abstract

Introduction: COVID-19 is responsible of severe hypoxaemia and acute respiratory distress syndrome (ARDS). Prone positioning improves oxygenation and survival in sedated mechanically patients with ARDS not related to COVID-19. Awake prone positioning is a simple and safe technique which improves oxygenation in non-intubated COVID-19 patients. We hypothesised that early prone positioning in COVID-19 patients breathing spontaneously in medical wards could decrease the rates of intubation or need for noninvasive ventilation or death.

Methods and analysis: PROVID-19 is an investigator-initiated, prospective, multicentre randomised, controlled, superiority trial comparing awake prone positioning to standard of care in hypoxaemic COVID-19 patients in 20 medical wards in France and Monaco. Patients are randomised to receive either awake prone position plus usual care or usual care alone with stratification on centres, body mass index and severity of hypoxaemia.The study objective is to compare the rate of treatment failure defined as a composite endpoint comprising the need for non-invasive ventilation (at two pressure levels) or for intubation or death, between the intervention group (awake prone position plus usual care) and the usual care (usual care alone) group at 28 days.

Ethics and dissemination: The protocol and amendments have been approved by the ethics committees (Comité de protection des personnes Ouest VI, France, no 1279 HPS2 and Comité Consultatif d'Ethique en matière de Recherche Biomédicale, Monaco, no 2020.8894 AP/jv), and patients are included after written informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number: NCT04363463.

Keywords: COVID-19; infectious diseases; respiratory infections.

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Conflict of interest statement

Competing interests: M-AN declares personal fees and non-financial support from Fisher & Paykel Healthcare.

Figures

Figure 1
Figure 1
Study outline.
Figure 2
Figure 2
Picture of prone position.
See this image and copyright information in PMC

References

    1. Suleyman G, Fadel RA, Malette KM, et al. . Clinical characteristics and morbidity associated with coronavirus disease 2019 in a series of patients in metropolitan Detroit. JAMA Netw Open 2020;3:e2012270. 10.1001/jamanetworkopen.2020.12270 - DOI - PMC - PubMed
    1. Argenziano MG, Bruce SL, Slater CL, et al. . Characterization and clinical course of 1000 patients with coronavirus disease 2019 in New York: retrospective case series. BMJ 2020;369:m1996. 10.1136/bmj.m1996 - DOI - PMC - PubMed
    1. Wolfisberg S, Gregoriano C, Struja T, et al. . Comparison of characteristics, predictors and outcomes between the first and second COVID-19 waves in a tertiary care centre in Switzerland: an observational analysis. Swiss Med Wkly 2021;151:w20569. 10.4414/smw.2021.20569 - DOI - PubMed
    1. Pavlov I, He H, McNicholas B, et al. . Awake prone positioning in Non-Intubated patients with acute hypoxemic respiratory failure due to COVID-19. Respir Care 2021:respcare.09191. 10.4187/respcare.09191 - DOI - PubMed
    1. Jayakumar D, Ramachandran Dnb P, Rabindrarajan Dnb E, et al. . Standard care versus awake prone position in adult Nonintubated patients with acute hypoxemic respiratory failure secondary to COVID-19 Infection-A multicenter feasibility randomized controlled trial. J Intensive Care Med 2021;36:918–24. 10.1177/08850666211014480 - DOI - PMC - PubMed

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