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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667923 on ClinicalTrials.gov