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Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure (COVID-VENT)

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ClinicalTrials.gov Identifier: NCT04445961
Recruitment Status : Completed
First Posted : June 24, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
I.M. Sechenov First Moscow State Medical University

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.

Condition or disease Intervention/treatment
SARS Pneumonia Diagnostic Test: Respiratory mechanics measurement Diagnostic Test: Gas exchange measurement

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.

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : August 14, 2020
Actual Study Completion Date : August 14, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Respiratory mechanics measurement
    Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure
  • Diagnostic Test: Gas exchange measurement
    Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio and alveolar dead space


Primary Outcome Measures :
  1. Optimum positive end-expiratory pressure (PEEP) level [ Time Frame: 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)

  2. Optimum positive end-expiratory pressure (PEEP) level [ Time Frame: 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)

  3. Number of patients with recruitable lung [ Time Frame: 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

  4. Number of patients with recruitable lung [ Time Frame: 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 :
  1. Change in alveolar dead space [ Time Frame: 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

  2. Change in plethysmogram variability during recruitment maneuver [ Time Frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation ]
    Measurement of plethysmogram variability before and during recruitment maneuver

  3. Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio [ Time Frame: 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

  4. Optimum positive end-expiratory pressure (PEEP) level [ Time Frame: 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)

  5. Change in driving pressure with different positive end-expiratory pressure (PEEP) levels [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with COVID-19 requiring respiratory support
Criteria

Inclusion Criteria:

  • all patients with COVID-19 and acute respiratory failure on invasive and noninvasive ventilation

Exclusion Criteria:

  • 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),
  • less than 24 ours in intensive care unit (ICU) by any reason,
  • lung emphysema,
  • primary lung diseases (chronic obstructive lung disease-COPD, interstitial lung diseases, etc) or tumour metastases in lungs,
  • chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),
  • atonic coma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445961


Locations
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Russian Federation
Sechenov University Clinic #1
Moscow, Russian Federation
Sechenov University Clinic #3
Moscow, Russian Federation
Sechenov University Clinic #4
Moscow, Russian Federation
Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Investigators
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Principal Investigator: Andrey I Yaroshetskiy, Dr.Med.Sc. Sechenov University
Publications of Results:
Other Publications:
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Responsible Party: I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT04445961    
Other Study ID Numbers: COVID-VENT
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by I.M. Sechenov First Moscow State Medical University:
SARS Pneumonia
ARDS
COVID-19
compliance
recruitability
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders