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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.
Nay, Mai-Anh; Planquette, Benjamin; Perrin, Christophe; Clément, Jérémy; Plantier, Laurent; Sève, Aymeric; Druelle, Sylvie; Morrier, Marine; Lainé, Jean-Baptiste; Colombain, Léa; Corvaisier, Grégory; Bizien, Nicolas; Pouget-Abadie, Xavier; Bigot, Adrien; Bernard, Louis; Nyamankolly, Elsa; Fossat, Guillaume; Boulain, Thierry.
  • Nay MA; Medical Intensive Care Unit, Centre Hospitalier Regional d'Orleans, Orleans, France mai-anh.nay@chr-orleans.fr.
  • Planquette B; Department of Respiratory Medicine, Hopital Europeen Georges Pompidou, Paris, France.
  • Perrin C; Innovative Therapies in Haemostasis, INSERM UMR S 1140, Biosurgical research lab (Carpentier Foundation), Université de Paris, Paris, France.
  • Clément J; Department of Pneumology and Pneumo-Covid Unit, Centre Hospitalier Princesse Grace, Monaco.
  • Plantier L; Department of Internal Medicine and General Medicine, Centre Hospitalier de Blois, Blois, France.
  • Sève A; Department of Pneumology and Respiratory Functional testing, Centre Hospitalier Régional Universitaire de Tours, Tours, France.
  • Druelle S; CEPR/INSERM UMR1100, Université de Tours, Tours, France.
  • Morrier M; Department of Infectious and Tropical Diseases, Centre Hospitalier Regional d'Orleans, Orleans, France.
  • Lainé JB; Department of Pneumology, Centre Hospitalier Regional d'Orleans, Orleans, France.
  • Colombain L; Departement of Infectious Diseases, Centre Hospitalier Départemental de la Vendée, La Roche-sur-Yon, France.
  • Corvaisier G; Department of Infectious and Tropical Diseases, Hospital Centre Le Mans, Le Mans, France.
  • Bizien N; Department of Infectious and Tropical Diseases, Centre Hospitalier de Perpignan, Perpignan, France.
  • Pouget-Abadie X; Department of Internal Medicine, Centre Hospitalier Bretagne Atlantique, Vannes, France.
  • Bigot A; Department of Pneumology, Centre Hospitalier Intercommunal de Cornouaille, Quimper, France.
  • Bernard L; Department of Internal Medicine and Infectious Diseases, Groupement Hospitalier La Rochelle Ré Aunis, La Rochelle, France.
  • Nyamankolly E; Department of Internal Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.
  • Fossat G; CEPR/INSERM UMR1100, Université de Tours, Tours, France.
  • Boulain T; Department of Infectious Diseases, Centre Hospitalier Régional Universitaire de Tours, Tours, France.
BMJ Open ; 12(7): e060320, 2022 07 08.
Article in English | MEDLINE | ID: covidwho-1932756
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2022 Document Type: Article Affiliation country: Bmjopen-2021-060320

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2022 Document Type: Article Affiliation country: Bmjopen-2021-060320