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Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality.
Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Awake prone positioning | Experimental | Prone positioning of patients on nasal high-flow oxygen therapy |
|
| Standard care | Active Comparator | Standard decubitus positioning of patients on nasal high-flow oxygen therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Awake Prone Positioning | Procedure | Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death | Up to 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation rate | Up to 28 days after randomization | |
| Mortality | Up to 28 days after randomization | |
| Days spent on mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Time in prone position | Total time spent in prone position, as recorded by nursing or respiratory therapists | Up to 28 days post randomization |
| Oxygenation (SpO2/FiO2 ratio) | Daily evolution of oxygenation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Pavlov, MD | Hôpital de Verdun | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôtel-Dieu de Gaspé | Gaspé | Quebec | G4X 2W2 | Canada | ||
| Hôpital de la Cité-de-la-Santé |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34425070 | Derived | Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20. | |
| 33177145 |
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| Standard care | Procedure | Patients will not receive any special instructions with regards to proning. |
|
| Until discharge, up to 24 weeks after randomization |
| Days spent in the ICU | Until discharge, up to 24 weeks after randomization |
| Hospital stay (in days) | From admission to discharge, up to 24 weeks after randomization |
| Until HFNC weaning, or up to 14 days after randomization, whichever is first |
| Laval |
| Quebec |
| H7M 3L9 |
| Canada |
| Montreal General Hospital, McGill University Healthcare Center | Montreal | Quebec | H3G 1A4 | Canada |
| Royal Victoria Hospital, McGill University Healthcare Center | Montreal | Quebec | H4A 3J1 | Canada |
| Hôpital de Verdun | Montreal | Quebec | H4G2A2 | Canada |
| Derived |
| Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520. |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D045169 | Severe Acute Respiratory Syndrome |
| D012131 | Respiratory Insufficiency |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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