Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS

Conditions
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COVID, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Corona Virus Infection

Intervention / Treatment
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* Other: Prone position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected. Patient treated by nasal high flow. Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio <300 mmHg (or SpO2 / FiO2 equivalent). Informed consent. Beneficiary or affiliated to a social security scheme. Exclusion Criteria: Indication of immediate tracheal intubation Significant acute progressive circulatory insufficiency Impaired alertness, confusion, restlessness Body mass index> 40 kg / m2 Chest trauma or other contraindication to prone position Pneumothorax Vulnerable person: safeguard of justice Pregnant or lactating woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Combination of prone position and HFNC | Other: Prone position<br>* 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.<br>|
| No Intervention: Control<br>Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic failure death or intubation | Therapeutic failure: death or intubation | 28 days within randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and safety of prone position in HFNC patients | Comfort measurement using a visual-analog scale. Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers. Intravascular lines displacement HFNC related events (hot air feeling, nasal lesions) | 28 days within randomization | 
| Efficacy of prone position in HFNC patients | Evolution of the oxygenation (SpO2/FiO2) in prone position. Efficacy Length of HFNC therapy Length of ICU stay Length of mechanical ventilation (in those who require intubation) ICU and hospital mortality | 28 days within randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRONE POSITION, High flow nasal cannula