COVID-VENT: Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure
Study Details
Study Description
Brief Summary
Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19 patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. The objective of the study is to evaluate the respiratory mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive.
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Detailed Description
In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) 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 goal of the study is the evaluation of the respiratory mechanics (peak inspiratory pressure (PIP), plateau pressure (Pplat), static compliance (Cstat), driving pressure (DP) at different positive end-expiratory pressure (PEEP) levels and different tidal volumes (Vt) (6-8 ml/kg ideal body weight), lung recruitability (by change of DP and oxygenation) and gas exchange (PaO2/FiO2 ratio and alveolar dead space) in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive for selection of safe and effective PEEP level, Vt, respiratory rate (RR) and inspiratory oxygen fraction (FiO2) during the whole course of mechanical ventilation - invasive or non-invasive.
This study is multicentral observational trial in 3 University clinics.
Study Design
Outcome Measures
Primary Outcome Measures
- Optimum positive end-expiratory pressure (PEEP) level [On day 1 during mechanical ventilation]
Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
- Optimum positive end-expiratory pressure (PEEP) level [On day 7 during mechanical ventilation]
Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
- Number of patients with recruitable lung [On day 1 during mechanical ventilation]
Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable
- Number of patients with recruitable lung [On day 7 during mechanical ventilation]
Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable
Secondary Outcome Measures
- Change in alveolar dead space [On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation]
Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement
- Change in plethysmogram variability during recruitment maneuver [On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation]
Measurement of plethysmogram variability before and during recruitment maneuver
- Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio [On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation]
Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement
- Optimum positive end-expiratory pressure (PEEP) level [On day 3, 5, 10, 14, 21 during mechanical ventilation]
Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)
- Change in driving pressure with different positive end-expiratory pressure (PEEP) levels [On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation]
Driving pressure calculation at different positive end-expiratory pressure (PEEP) levels (8, 10, 12, 14)
Eligibility Criteria
Criteria
Inclusion Criteria:
- all patients with COVID-19 and acute respiratory failure on invasive and noninvasive ventilation
Exclusion Criteria:
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Patients who reached the following goals at conventional oxygen therapy (oxygen flow < 15 l/min): peripheral capillary oxygen saturation(SpO2) > 93%, no visible work of auxiliary respiratory muscles, no fatigue, stable hemodynamics (no need in any catecholamines and/or life-threatening heart rhythm abnormalities),
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less than 24 ours in intensive care unit (ICU) by any reason,
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lung emphysema,
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primary lung diseases (chronic obstructive lung disease-COPD, interstitial lung diseases, etc) or tumour metastases in lungs,
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chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),
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atonic coma.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sechenov University Clinic #1 | Moscow | Russian Federation | ||
| 2 | Sechenov University Clinic #3 | Moscow | Russian Federation | ||
| 3 | Sechenov University Clinic #4 | Moscow | Russian Federation |
Sponsors and Collaborators
- I.M. Sechenov First Moscow State Medical University
Investigators
- Principal Investigator: Andrey I Yaroshetskiy, Dr.Med.Sc., Sechenov University
Study Documents (Full-Text)
None provided.More Information
Publications
- COVID-VENT