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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 22, 2020
First Posted Date June 24, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date May 1, 2020
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2020)
  • 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)
  • 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)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 23, 2020)
  • 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
  • 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
  • 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
  • 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)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure
Official Title Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with COVID-19 requiring respiratory support
Condition SARS Pneumonia
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 26, 2020)
117
Original Estimated Enrollment
 (submitted: June 23, 2020)
70
Actual Study Completion Date August 14, 2020
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04445961
Other Study ID Numbers COVID-VENT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party I.M. Sechenov First Moscow State Medical University
Study Sponsor I.M. Sechenov First Moscow State Medical University
Collaborators Not Provided
Investigators
Principal Investigator: Andrey I Yaroshetskiy, Dr.Med.Sc. Sechenov University
PRS Account I.M. Sechenov First Moscow State Medical University
Verification Date June 2020