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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01121-38 | Other Identifier | IdRCB | |
| DR200125 | Other Identifier | University Hospital, Tours |
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Acute Respiratory Distress Syndrome (ARDS) induces high mortality, particularly in the context of COVID-19 disease. Preliminary data from patients with ARDS related to COVID-19 disease appear to show significant effectiveness of prone positioning in intubated patients in terms of oxygenation as well as nasal high flow therapy before intubation. It should be noted that in Jiangsu province, secondarily affected, nasal high flow combined with the prone position was successfully integrated into care protocols.
The investigators hypothesize that the combined application of nasal high flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for tracheal intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.
Investigators hypothesize that the combined application of nasal high-flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.
Acute Respiratory Distress Syndrome (ARDS) induces high mortality, particularly in the context of COVID-19 disease. In patients with ARDS who are mechanically ventilated invasively through a tracheal tube and with a PaO2/FiO2 ratio (arterial oxygen partial pressure to inspired oxygen fraction ratio) of less than 150 mmHg, prone positioning significantly reduced mortality. Furthermore, nasal high flow, a non-invasive respiratory support and oxygenation technique, reduced the need for tracheal intubation and reduced mortality among the most severe patients (PaO2/FiO2 ratio less than 200 mmHg) suffering from acute hypoxemic respiratory failure. Prone positioning of ARDS patients treated with nasal high-flow was evaluated in 20 patients with predominantly viral pneumonia. The prone positioning was found to be feasible and associated with an increased PaO2/FiO2 ratio. Preliminary data from patients with ARDS related to COVID-19 disease appear to show a significant effect of prone positioning in intubated patients in terms of oxygenation improvement as well as nasal high-high flow appears effective in non-intubated patients. For instance, nearly half intensive care unit patients described in the princeps cohort in Wuhan City, Hubei Province, China, had received nasal high-flow. It should be noted that in Jiangsu province, secondarily affected, nasal high-flow combined with prone positioning was successfully integrated into care protocols.
Investigators hypothesize that the combined application of nasal high-flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prone decubitus group | Experimental | Prone positioning of patients on nasal high-flow oxygen therapy with usual care |
|
| Control group | No Intervention | Patients on nasal high-flow oxygen therapy with usual care and positioned in supine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone decubitus | Other | According to the tolerance, the objective is to spend as much time as possible, up to 16 hours and beyond in prone position every 24 hours. At least two sessions of at least 30 minutes each must be performed daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic failure within 14 days of randomization | Therapeutic failure is defined by death or intubation or use of non-invasive ventilation at two pressure levels. | From randomization to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic failure within 28 days of randomization | Therapeutic failure is defined by death or intubation or use of non-invasive ventilation at two pressure levels. | From randomization to day 28 |
| Timeframe of intubation or death |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breastfeeding woman
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| Name | Affiliation | Role |
|---|---|---|
| Yonatan PEREZ, MD | No affiliation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit, University Hospital, Aix | Aix-en-Provence | 13616 | France | |||
| Medical Intensive Care Unit, University Hospital, Amiens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34425070 | Result | 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. | |
| 34861160 |
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Individual participant data after de-identification can be obtained by contacting the corresponding author.
Data will be available immediately following publication and ending in 5 years.
Contact with the corresponding author.
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| From randomization to day 28 |
| Timeframe of therapeutic escalation (in case of non-invasive ventilation at two pressure levels) | From randomization to day 28 |
| Evolution of oxygenation (PaO2/FiO2 ratio or SpO2/FiO2 surrogate) over the 14 days following randomization | From randomization to day 14 |
| Evolution of the SpO2/FiO2 ratio during the first prone session | From randomization to day 1 |
| Evolution of the ROX index during the first prone session | ROX index is the ratio of pulse oximetry (SpO2)/fraction of inspired oxygen (FiO2) to respiratory rate. | From randomization to day 1 |
| Evolution of the World Health Organization disease severity score of COVID | Score reaches from 1 to 7, 7 indicates worse outcome | From randomization to day 28 |
| Patient comfort before, during and after the first prone position session | Comfort evaluted by the patient through a visual analogical scale | From randomization to day 1 |
| Occurrence of skin lesions on the anterior surface of the body | From randomization to day 28 |
| Displacement of invasive devices during reversals | Invasive devices include : central and peripheric vascular catheters, tracheal tube, urinary catheter, chest tubes. | From randomization to day 28 |
| Days of nasal High-Flow therapy use in the general population, in non-intubated patients and in intubated patients | From randomization to day 28 |
| Days spent in the intensive care unit and in the hospital | From randomization to day 28 |
| Mortality in the intensive care unit and in the hospital | From randomization to day 28 |
| Ventilator-free-days within 28 days of randomization | From randomization to day 28 |
| Amiens |
| 80054 |
| France |
| Intensive Care Unit, Hospital, Argenteuil | Argenteuil | 95100 | France |
| Medical Intensive Care Unit, Hospital, Béthune | Béthune | 62408 | France |
| Intensive Care Unit, Hospital, | Blois | 41016 | France |
| Medical Intensive Care Unit, University Hospital, Brest | Brest | 29609 | France |
| Medical Intensive Care Unit, University Hospital, Caen | Caen | 14033 | France |
| Intensive Care Unit, Louis Mourier-APHP | Colombes | 92700 | France |
| Intensive Care Unit, Hospital, Dax | Dax | 40107 | France |
| Medical Intensive Care Unit, University Hospital, Dijon | Dijon | 21033 | France |
| Medical Intensive Care Unit, University Hospital, Grenoble | Grenoble | France |
| Intensive Care Unit, Hospital, La Roche-sur-Yon | La Roche-sur-Yon | 85925 | France |
| Intensive Care Unit, Hospital, Le Mans | Le Mans | 72037 | France |
| Intensive Care Unit, University Hospital, Lille | Lille | 59037 | France |
| Medical Intensive Care Unit, University Hospital, Nantes | Nantes | 44093 | France |
| Medical Intensive Care Unit, University Hospital, Nice | Nice | 06202 | France |
| Medical Intensive Care Unit, Hospital, Orléans | Orléans | 45067 | France |
| Medical Intensive Care Unit, Tenon-APHP | Paris | 75020 | France |
| Medical Intensive Care Unit, University Hospital, Poitiers | Poitiers | 86021 | France |
| Medical Intensive Care Unit, University Hospital, Tours | Tours | 37044 | France |
| Surgical Intensive Care Unit, University Hospital, Tours | Tours | 37170 | France |
| Intensive Care Unit, Hospital, Valence | Valence | 26953 | France |
| Medical Intensive Care Unit, University Hospital, Nancy | Vandœuvre-lès-Nancy | 54511 | France |
| Intensive Care Unit, Hospital, Vannes | Vannes | 56017 | France |
| Result |
| Ibarra-Estrada M, Li J, Laffey JG, Pavlov I, Roca O, Perez Y, McNicholas B, Vines D, Tavernier E, Ehrmann S. Prone positioning might reduce the need for intubation in people with severe COVID-19 - Authors' reply. Lancet Respir Med. 2021 Dec;9(12):e111. doi: 10.1016/S2213-2600(21)00449-5. No abstract available. |
| 33177145 | Result | 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 |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| 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 |
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