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The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most serious is acute respiratory distress syndrome (ARDS).
The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation in mild forms to invasive mechanical ventilation in the most severe forms.
Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al showed that PP and high flow oxygenation reduced the intubation in patients with moderate to severe ARDS.
The investigators hypothesize that the use of PP in spontaneously ventilation patients under oxygen standard could decrease incidence of intubation or non-invasive ventilation or death compared to conventional positioning management in medical departments.
This is a multicenter randomized controlled study. 400 patients with COVID-19 documentation and undergoing oxygen therapy will be randomly assigned, with a 1:1 ratio, to conventional positioning or repeated prone sessions.
The control group will have conventional positioning: semi-seated in bed or seated in a chair. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position).
The intervention group will have:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional positioning | No Intervention | semi-seated in bed or seated in a chair during the day. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position). | |
| Interventional positioning : prone position | Experimental | Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prone position | Other | Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups. | To show that PP in spontaneously ventilation patients could reduce the risk of acquiring the following event (composite endpoint):
| Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration in days for the change of 2 points on the WHO ordinal scale | Show that the use of prone position improves the WHO ordinal scale score by 2 points faster (after randomization) | Day 28 |
| Rate (%) of intubation and invasive ventilation in the 2 randomization groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai-Anh NAY, Dr | CHR Orléans | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de Blois | Blois | 41016 | France | |||
| CH de DAX |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32159735 | Background | Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available. | |
| 31986264 | Background | Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. |
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Randomized controlled multicenter trial Ratio 1:1
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Show that prone position with spontaneous ventilation reduces the need for endotracheal intubation and invasive mechanical ventilation |
| Day 28 |
| Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups | Show that prone position with spontaneous ventilation reduces the use of non-invasive ventilation at two pressure levels | Day 28 |
| Duration of oxygen therapy in the 2 randomization groups. | Show that prone position in spontaneous ventilation reduces the time under oxygen therapy. | Day 28 |
| Duration of hospitalization in the 2 randomization groups. | Show that prone position reduces the length of hospitalization. | Day 28 |
| Hospital mortality and mortality at D28 in the 2 randomization groups | Compare the hospital mortality of the 2 groups | Day 28 |
| Rate (%) of need for transfer to intensive care unit | Compare the incidence of the need for resuscitation transfer between the two groups. | Day 28 |
| Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days. | Compare the impact of the use of non-invasive ventilation and intubation on the entire hospital stay when the hospital stay is longer than 28 days between the two groups. | 1 year |
| Dax |
| 40100 |
| France |
| CHD de VENDEE | La Roche-sur-Yon | 85925 | France |
| CH de LA ROCHELLE | La Rochelle | 17019 | France |
| CH Le Mans | Le Mans | 72037 | France |
| CH Mont de MArsan | Mont-de-Marsan | 40012 | France |
| CHR d'Orléans - Service Pneumologie | Orléans | 45000 | France |
| CHR d'Orleans - Service Maladies Infectieuses | Orléans | 45067 | France |
| HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition | Paris | 75010 | France |
| Hopital Européen Georges Pompidou | Paris | France |
| Hopital Lariboisiere - Medecine Interne | Paris | France |
| Hopital Lariboisiere | Paris | France |
| CH de PERPIGNAN - Service Maladies infectieuses | Perpignan | 66046 | France |
| Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau | Quimper | 29000 | France |
| CHRU de Tours - Service Médecine interne et immunologie Clinique | Tours | 37000 | France |
| CHRU de Tours - Service Pneumologie | Tours | 37000 | France |
| CHRU DE TOURS - Service Médecine interne et maladies infectieuses | Tours | 37044 | France |
| CH Bretagne Atlantique | Vannes | 56017 | France |
| centre Hospitalier Princesse Grace | Monaco | Monaco |
| 32171076 | Background | Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. |
| 32167524 | Background | Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. |
| 37330512 | Derived | Nay MA, Hindre R, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Jamard S, Nyamankolly E, Planquette B, Fossat G, Boulain T. Prone position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomised controlled trial. Crit Care. 2023 Jun 17;27(1):240. doi: 10.1186/s13054-023-04529-z. |
| 35803621 | Derived | Nay MA, Planquette B, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Bernard L, Nyamankolly E, Fossat G, Boulain T. 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. 2022 Jul 8;12(7):e060320. doi: 10.1136/bmjopen-2021-060320. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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