Status:

COMPLETED

Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome

Lead Sponsor:

I.M. Sechenov First Moscow State Medical University

Conditions:

Covid19

ARDS

Eligibility:

All Genders

18-80 years

Brief 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 base...

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...

Eligibility Criteria

Inclusion

  • at least one of the following criteria: fatigue, Patrick scale 5 points, SpO2\<92% on standard oxygen therapy (\<15 l/min) or continuous positive airway pressure (CPAP)-therapy with oxygen flow\<15 l/min

Exclusion

  • pregnancy
  • age less than 18 or more than 80 years
  • life-threatening heart rhythm abnormalities and/or systolic blood pressure \< 80 mmHg despite norepinephrine at a dose \> 2 µg/kg/min
  • primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumour metastases in lungs
  • chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure)
  • Glasgow cona score \< 14
  • inability to swallow
  • upper airways obstruction

Key Trial Info

Start Date :

October 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 31 2021

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04667923

Start Date

October 1 2020

End Date

August 31 2021

Last Update

November 11 2021

Active Locations (1)

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1

Sechenov University clinic #4

Moscow, Russia