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
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 oxyg...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e060320.full |
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| author | Benjamin Planquette Christophe Perrin Thierry Boulain Mai-Anh Nay Louis Bernard Laurent Plantier Léa Colombain Jérémy Clément Aymeric Sève Sylvie Druelle Marine Morrier Jean-Baptiste Lainé Grégory Corvaisier Nicolas Bizien Xavier Pouget-Abadie Adrien Bigot Elsa Nyamankolly Guillaume Fossat |
| author_facet | Benjamin Planquette Christophe Perrin Thierry Boulain Mai-Anh Nay Louis Bernard Laurent Plantier Léa Colombain Jérémy Clément Aymeric Sève Sylvie Druelle Marine Morrier Jean-Baptiste Lainé Grégory Corvaisier Nicolas Bizien Xavier Pouget-Abadie Adrien Bigot Elsa Nyamankolly Guillaume Fossat |
| author_sort | Benjamin Planquette |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-738a501428dd4115be4fbe978c605c94 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-738a501428dd4115be4fbe978c605c942025-01-30T14:05:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-060320Does 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 protocolBenjamin Planquette0Christophe Perrin1Thierry Boulain2Mai-Anh Nay3Louis Bernard4Laurent Plantier5Léa Colombain6Jérémy Clément7Aymeric Sève8Sylvie Druelle9Marine Morrier10Jean-Baptiste Lainé11Grégory Corvaisier12Nicolas Bizien13Xavier Pouget-Abadie14Adrien Bigot15Elsa Nyamankolly16Guillaume Fossat17Innovative Therapies in Haemostasis, INSERM UMR S 1140, Biosurgical research lab (Carpentier Foundation), Université de Paris, Paris, FranceService de pneumologie, Centre Hospitalier Princesse Grace, Monaco, MonacoMedical Intensive Care Unit, Centre Hospitalier Regional d`Orleans, Orleans, FranceMedical Intensive Care Unit, Centre Hospitalier Regional d`Orleans, Orleans, FranceCEPR/INSERM UMR1100, Université de Tours, Tours, FranceCEPR/INSERM UMR1100, Université de Tours, Tours, FranceDepartment of Infectious and Tropical Diseases, Centre Hospitalier de Perpignan, Perpignan, FranceDepartment of Internal Medicine and General Medicine, Centre Hospitalier de Blois, Blois, FranceDepartment of Infectious and Tropical Diseases, Centre Hospitalier Regional d`Orleans, Orleans, FranceDepartment of Pneumology, Centre Hospitalier Regional d`Orleans, Orleans, FranceDepartement of Infectious Diseases, Centre Hospitalier Départemental de la Vendée, La Roche-sur-Yon, FranceDepartment of Infectious and Tropical Diseases, Hospital Centre Le Mans, Le Mans, FranceDepartment of Internal Medicine, Centre Hospitalier Bretagne Atlantique, Vannes, FranceDepartment of Pneumology, Centre Hospitalier Intercommunal de Cornouaille, Quimper, FranceDepartment of Internal Medicine and Infectious Diseases, Groupement Hospitalier La Rochelle Ré Aunis, La Rochelle, FranceDepartment of Internal Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, FranceDepartment of Internal Medicine and Infectious Diseases, Hospital Dax Côte d’Argent, Dax, FranceMedical Intensive Care Unit, Centre Hospitalier Regional d`Orleans, Orleans, FranceIntroduction 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.https://bmjopen.bmj.com/content/12/7/e060320.full |
| spellingShingle | Benjamin Planquette Christophe Perrin Thierry Boulain Mai-Anh Nay Louis Bernard Laurent Plantier Léa Colombain Jérémy Clément Aymeric Sève Sylvie Druelle Marine Morrier Jean-Baptiste Lainé Grégory Corvaisier Nicolas Bizien Xavier Pouget-Abadie Adrien Bigot Elsa Nyamankolly Guillaume Fossat 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/7/e060320.full |
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