The Prone Position in Covid-19 Affected Patients

Study Overview
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Brief Summary
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The prone position during mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The objective of the study is to evaluate the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia.

Detailed Description
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BACKGROUND: It has been shown that the prone position (PP) during mechanical ventilation (VM) in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The reduced mortality, however, is not only caused by an increase in oxygen, but also by the ability of the PP to reduce the damage associated with mechanical ventilation (VILI). Studies show that the benefits of PP are also present in non-intubated patients; the PP prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP). Moreover, a reduction in the need for intubation and therefore hospitalization in the ICU would be particularly useful in a context of great health emergency with limited resources. The objective of the study is to value the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index. STUDY DESIGN: This is a monocentric study that will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen support or CPAP. Sample size (n. Patients): 56 The duration of enrollment is estimated in 1 month. Patients will be monitored until discharged from the hospital. The overall duration of the study is estimated to be 1 year (including enrollment, follow up and data analysis). The patient will be enrolled in the study when consent is obtained. The following data will be collected: Patient registration Demographic and anthropometric data Comorbidity and lifestyle habits Hospitalization data Blood chemistry tests Ventilation parameters After 10 minutes and at the end of pronation, the feasibility of pronation and ventilation parameters will also be assessed. STATISTICAL ANALYSIS: Clinical data relating to enrolled patients will be analysed by means of descriptive statistics on continuous quantitative variables using indicators chosen on the basis of the distributional form. Categorical variables will be described in percentages. Hypotheses on PaO2 / FiO2 performance will be verified through the T test for paired data if the distributional form allows it or alternatively the Wilcoxon test will be used. In this case we will proceed with a recalculation of the power study.

Official Title
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Study of the Feasibility and Usefulness of the Prone Position in Patients With Respiratory Distress From Covid-19 Not Intubated, in Spontaneous Breath in Oxygen Therapy or Cpap

Conditions
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Sars-CoV2

Intervention / Treatment
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* Procedure: Prone position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> = 18 years old or <= 75 years old Diagnosis of COVID related pneumonia requiring oxygen or CPAP support Exclusion Criteria: pregnant patients patients with impaired consciousness and / or uncooperative patients with NYHA class> II patients with high proBNP patients with COPD contraindications evidenced by the physicians

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| covid-19 pneumonia related patients<br>This study will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen support or CPAP. | Procedure: Prone position<br>* The objective of the study is to value the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index; the PP also prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).<br>* Other names: PP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in whom the prone position caused an increase in oxygenation | Measure the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index. | Until patient discharge from the hospital (approximately 1 month after enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of prone position | Measure the feasibility of the prone position in terms of patient comfort and health resources in a context of a national health emergency. | Until patient discharge from the hospital (approximately 1 month after enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, sars-covid-2