Sechenov University clinic #4
Moscow, Russia
NCT Number: NCT04667923
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Observational
Moscow, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: On day 28
Frequency of NIV failure
Time frame: On day 28
Mortality on day 28
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Measurement of arterial carbon dioxide tension, minute ventilation and calculation of ventilatory ratio
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Measurement of exhaled tidal volume
Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Calculation of the Patrick's scale (minimum 0 points, maximum 5 points, more points means worse outcome)
I.M. Sechenov First Moscow State Medical University
Other
Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome to Prevent Tracheal Intubation: the COVID-NIV Study
Acronym: COVID-NIV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04556513
ARDS, COVID-19
Dijon, France
View Trial DetailsNCT04692779
ARDS, COVID-19
Chicago, Illinois, United States
View Trial DetailsNCT04487769
ARDS, COVID-19
Amsterdam, Netherlands
View Trial DetailsNCT04494386
ARDS, COVID-19
Miami, Florida, United States
View Trial Details