Prone Positioning in COVID-19 Patients

Study Overview
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Brief Summary
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Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3). The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6). Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7). Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the recruitability position of the lung.in COVID-ARDS.

Detailed Description
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Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3). The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6). Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the oxygenation, respiratory mechanics and recruitability position of the lung in COVID-ARDS.

Official Title
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The Effect of Prone Positioning on Oxygenation and Respiratory Mechanics in Patients With COVID-19 Pneumonia

Conditions
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ARDS, Coronavirus Disease 2019, Mechanical Ventilation Pressure High

Intervention / Treatment
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* Other: Oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with laboratory-confirmed COVID-19 admitted to the ICU The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives, Exclusion Criteria: Pregnancy Pneumothorax and or chest tube Chronic obstructive lung disease interstitial lung disease intraabdominal hypertension increase in intracranial blood pressure Haemodynamic unstability requiring vasopressors

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prone Positioning<br>Patients will be ventilated in volume-controlled mode with Vt at 6 ml/kg of predicted body weight. Prone positioning will be performed over periods of 16 hours when PaO2/FiO2 was persistently lower than 150 mm Hg. Flow, volume, and airway pressure will bw measured by ventilators. Measurements of oxygenation and respiratory mechanics were performed at 5 and 15 cmH20 PEEP levels and will be repeated every season as before first period of prone positioning, before supine positioning, and again before second period of prone positioning. Total PEEP and plateau pressure will be measured by a short end-expiratory and an end-inspiratory occlusion respectively. Complete airway closure will be assessed by performing a low-flow (4 L/min) inflation( PV tool) (9). The potential for lung recruitment will be assessed by means of the R/I ratio (10). | Other: Oxygenation<br>* Oxygenation will be calculated as PaO2/ FiO2 ratio.Static compliance will be calculated as tidal volume divided driving pressure.The potential for lung recruitment will be assessed by means of the R/I ratio (10).<br>* Other names: static compliance, Recruitability;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation | PaO2/FiO2 | intubation + 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static compliance | Tidal volume divided driving pressure | intubation + 48 hours | 
| Recruitability | recruitment to inflation ratio | intubation + 48 hours |