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NCT Number: NCT04667923

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sechenov University clinic #4

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Respiratory monitoring

Diagnostic Test

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

Respiratory muscles ultrasound

Diagnostic Test

Measurement of the diaphragm thickening fraction, assessment of the contraction of scalene and sternocleidomastoid muscles

Electro impedance tomography

Diagnostic Test

Measurement of the lung impedance changes in 4 quadrants, measurement of regional ventilation delay in 4 quadrants

Capnography

Diagnostic Test

Measurement of end-tidal carbon dioxide tension

Arterial blood gas

Diagnostic Test

Measurement of the oxygen partial pressure and the carbon dioxide partial pressure

Quasistatic pressure-volume curve

Diagnostic Test

Quasistatic pressure-volume curve

Primary outcomes

  1. Intubation rate

    Time frame: On day 28

    Frequency of NIV failure

  2. Mortality

    Time frame: On day 28

    Mortality on day 28

Secondary outcomes

  1. Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio

    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

  2. Change in ventilatory ratio

    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

  3. Change in alveolar dead space

    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

  4. Change in tidal volume

    Time frame: Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation

    Measurement of exhaled tidal volume

  5. Change in accessory respiratory muscles workload

    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)

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome to Prevent Tracheal Intubation: the COVID-NIV Study

Acronym: COVID-NIV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Nov 11, 2021

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.

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