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NCT Number: NCT04445961

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

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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Key information

Conditions

SARS Pneumonia Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Patient Acceptance of Health Care Patient Compliance Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sechenov University Clinic #1, Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory mechanics measurement

Diagnostic Test

Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure

Gas exchange measurement

Diagnostic Test

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study

Acronym: COVID-VENT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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