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Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.
Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.
Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.
Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.
Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Combination of prone position and HFNC |
|
| Control | No Intervention | Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone position | Other | HFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic failure death or intubation | Therapeutic failure: death or intubation | 28 days within randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and safety of prone position in HFNC patients |
| 28 days within randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| 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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Data will be shared to perform a meta-trial including other studies that assess the effectiveness of prone position in COVID-19 patients supported with nasal high flow.
No patient identifying data will be transferred to the data repository. The data set will use pseudoanonymised data. The consent process for the study will highlight that this is a meta-trial and that both aggregated and individual data without personal identifying features will be used to formulate the results from the study. Local regulation for the management of patient data needs to be adhered to as part of agreement for involvement in the study.
Data will be shared during the study at two points, Time 1 An interim analysis at 200 patients in which aggregated outcome data for the primary outcome and severe adverse effects will be analyzed
Time 2 Final analysis outlining salient clinical feature of patients for each group, outcomes
Data will be shared when first 200 patients (counting the 5 studies participating in the meta-trial) will be included and at the end of inclusion
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D003333 | Coronaviridae Infections |
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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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| Efficacy of prone position in HFNC patients |
| 28 days within randomization |
| 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. |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |