Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome
Condition: Covid19; ARDS
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Observational

Summary: 
      Non-invasive ventilation can allow to avoid intubation and improve outcomes in
      moderate-to-severe COVID-19-associated acute respiratory distress-syndrome (ARDS). Data on
      NIV parameters adjustment based on expanded respiratory and gas exchange monitoring in
      COVID-19 associated ARDS is limited. Appropriate adjustment of the inspiratory positive
      airway pressure (IPAP) set as a point of the balance between minimal work of breathing
      (minimum point of W.Patrick scale for assessment of the accessory respiratory muscles and
      minimum diaphragm thickening fraction) and minimum tidal volume, and respiratory rate can
      decrease NIV failure in moderate-to-severe COVID-ARDS. The objective of the study is to
      evaluate the ability of non-invasive ventilation guided with expanded respiratory monitoring
      to decrease the intubation rate in in moderate-to-severe COVID-ARDS.
    

Detailed description: 
      In December 2019, an outbreak of a novel coronavirus emerged in Wuhan, China and rapidly
      spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on
      March 11th, 2020. The clinical disease (COVID-19) results in critical illness in about 5% of
      patients with predominant acute respiratory failure.

      The objective of the study is to evaluate the ability of non-invasive ventilation guided with
      expanded respiratory monitoring to decrease the intubation rate in in moderate-to-severe
      COVID-ARDS. Investigators will set IPAP as a point of the balance between minimal work of
      breathing (minimum point of W.Patrick scale for assessment of the accessory respiratory
      muscles, and minimum diaphragm thickening fraction) and minimum tidal volume, and respiratory
      rate. Investigators will set expiratory pressure at 8-10 cm of water and the inspiratory
      oxygen fraction (FiO2) to reach oxygen saturation by pulse oximetry (SpO2) 95%. All gas
      exchange measurements will be set at IPAP level. For gas exchange assessment investigators
      will measure partial oxygen tension in the arterial blood (PaO2), partial carbon dioxide
      tension in arterial blood (PaCO2), end-tidal carbon dioxide tension (PetCO2), then will
      calculate PAO2/FiO2, alveolar dead space (Vd alv) and ventilatory ratio (VR). Investigators
      will measure expiratory tidal volume (VT), respiratory rate (RR), peak inspiratory flow (PIF)
      and inspiratory time at 3 levels: at the set IPAP, at IPAP+4 cm of water and at IPAP-4 cm of
      water. Measurements will be repeated on day 1, 3, 5, 7, 14 and 21 of NIV. NIV failure is
      determined as one of the following at set IPAP 26 cm of water and FiO2 100%: fatigue, Patrick
      scale 5 points, SpO2<92%, apnoea, hemodynamic instability or Glasgow coma score <14 points.

      In patients with NIV failure after intubation and every 7 day after intubation investigators
      will measure plateau pressure and calculate the driving pressure at PEEP 8-10-12-14 cm of
      water and VT 6 ml/kg predicted body weight (PBW), and VT+100 ml and VT+200 ml at PEEP 8 cm of
      water, plot static pressure volume-curve at positive end-expiratory pressure (PEEP) 5 and 14
      cm of water, and perform electro impedance tomography.

      This study is an observational trial in the ICU of the University hospital.
    

Intervention name(s): Respiratory monitoring; Respiratory muscles ultrasound; Electro impedance tomography; Capnography; Arterial blood gas; Quasistatic pressure-volume curve
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Measurement of the tidal volume, peak inspiratory flow, inspiratory time, respiratory rate and the pressure gap during triggering on NIV and plateau pressure on mechanical ventilation; Measurement of the diaphragm thickening fraction, assessment of the contraction of scalene and sternocleidomastoid muscles; Measurement of the lung impedance changes in 4 quadrants, measurement of regional ventilation delay in 4 quadrants; Measurement of end-tidal carbon dioxide tension; Measurement of the oxygen partial pressure and the carbon dioxide partial pressure; Quasistatic pressure-volume curve
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with COVID-19-associated moderate-to-severe acute respiratory distress-syndrome