The Prone Position in Covid-19 Affected Patients
Condition: Sars-CoV2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      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: 
      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.
    

Intervention name(s): Prone position
Intervention type(s): Procedure
Intervention description(s): 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).
Other intervention name(s): PP
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The 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 or CPAP support.
      
Keywords: COVID-19; sars-covid-2