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

NCT04667923 | Completed FDA Device

• 1 other identifier: 002-NIV-COVID
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• Intubation rate

  Frequency of NIV failure

  On day 28

• Mortality

  Mortality on day 28

  On day 28

Secondary Outcomes (5)

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

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

• Change in ventilatory ratio

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

• Change in alveolar dead space

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

• Change in tidal volume

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

• Change in accessory respiratory muscles workload

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with COVID-19-associated moderate-to-severe acute respiratory distress-syndrome

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov University clinic #4

Moscow, Russia

Location

Related Publications (5)

• 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.

  PMID: 33067061 BACKGROUND

• 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.

  PMID: 19961634 BACKGROUND

• 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. No abstract available.

  PMID: 32809841 BACKGROUND

• 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. doi: 10.1164/ajrccm.153.3.8630538.

  PMID: 8630538 BACKGROUND

• Yaroshetskiy AI, Merzhoeva ZM, Tsareva NA, Trushenko NV, Nuralieva GS, Konanykhin VD, Krasnoshchekova AP, Avdeev SN. Breathing pattern, accessory respiratory muscles work, and gas exchange evaluation for prediction of NIV failure in moderate-to-severe COVID-19-associated ARDS after deterioration of respiratory failure outside ICU: the COVID-NIV observational study. BMC Anesthesiol. 2022 Oct 1;22(1):307. doi: 10.1186/s12871-022-01847-7.

  PMID: 36183064 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Capnography; Blood Gas Analysis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Andrey I Yaroshetskiy, MD, PhD, ScD

  Sechenov University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 16, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: November 11, 2021

Record last verified: 2020-12

Locations

RU (1)