Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome
NCT04667923 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80
Last updated 2021-11-11
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.
Conditions
- Covid19
- ARDS
Interventions
- DIAGNOSTIC_TEST
-
Respiratory monitoring
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
- DIAGNOSTIC_TEST
-
Respiratory muscles ultrasound
Measurement of the diaphragm thickening fraction, assessment of the contraction of scalene and sternocleidomastoid muscles
- DIAGNOSTIC_TEST
-
Electro impedance tomography
Measurement of the lung impedance changes in 4 quadrants, measurement of regional ventilation delay in 4 quadrants
- DIAGNOSTIC_TEST
-
Capnography
Measurement of end-tidal carbon dioxide tension
- DIAGNOSTIC_TEST
-
Arterial blood gas
Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
- DIAGNOSTIC_TEST
-
Quasistatic pressure-volume curve
Quasistatic pressure-volume curve
Sponsors & Collaborators
-
I.M. Sechenov First Moscow State Medical University
lead OTHER
Principal Investigators
-
Andrey I Yaroshetskiy, MD, PhD, ScD · Sechenov University
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-01
- Primary Completion
- 2021-06-30
- Completion
- 2021-08-31
- FDA Device
- Yes
Countries
- Russia
Study Locations
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