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

Covid19 Clinical Trial

— COVID-NIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667923
• Other study ID #: 002-NIV-COVID
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2020
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• COVID-19
• Covid19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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
• Respiratory muscles ultrasound
Measurement of the diaphragm thickening fraction, assessment of the contraction of scalene and sternocleidomastoid muscles
• Electro impedance tomography
Measurement of the lung impedance changes in 4 quadrants, measurement of regional ventilation delay in 4 quadrants
• Capnography
Measurement of end-tidal carbon dioxide tension
• Arterial blood gas
Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
• Quasistatic pressure-volume curve
Quasistatic pressure-volume curve

Locations

Country	Name	City	State
Russian Federation	Sechenov University clinic #4	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

Agarwal R, Handa A, Aggarwal AN, Gupta D, Behera D. Outcomes of noninvasive ventilation in acute hypoxemic respiratory failure in a respiratory intensive care unit in north India. Respir Care. 2009 Dec;54(12):1679-87. — View Citation

Avdeev SN, Yaroshetskiy AI, Tsareva NA, Merzhoeva ZM, Trushenko NV, Nekludova GV, Chikina SY. Noninvasive ventilation for acute hypoxemic respiratory failure in patients with COVID-19. Am J Emerg Med. 2021 Jan;39:154-157. doi: 10.1016/j.ajem.2020.09.075. Epub 2020 Oct 1. — View Citation

Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. — View Citation

Yaroshetskiy AI, Avdeev SN, Konanykhin VD. Acute Respiratory Distress Syndrome in COVID-19: Do All These Patients Definitely Require Intubation and Mechanical Ventilation? Am J Respir Crit Care Med. 2020 Nov 15;202(10):1480-1481. doi: 10.1164/rccm.202007-2713LE. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate	Frequency of NIV failure	On day 28
Primary	Mortality	Mortality on day 28	On day 28
Secondary	Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio	Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement	Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Secondary	Change in ventilatory ratio	Measurement of arterial carbon dioxide tension, minute ventilation and calculation of ventilatory ratio	Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Secondary	Change in alveolar dead space	Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement	Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Secondary	Change in tidal volume	Measurement of exhaled tidal volume	Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation
Secondary	Change in accessory respiratory muscles workload	Calculation of the Patrick's scale (minimum 0 points, maximum 5 points, more points means worse outcome)	Days 1, 3, 5, 7, 10, 14, 21 during noninvasive ventilation