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

August 26, 2020 updated by: I.M. Sechenov First Moscow State Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Sechenov University Clinic #4
      • Moscow, Russian Federation
        • Sechenov University Clinic #1
      • Moscow, Russian Federation
        • Sechenov University Clinic #3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with COVID-19 requiring respiratory support

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
On day 1 during mechanical ventilation
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)
On day 7 during mechanical ventilation
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
On day 1 during mechanical ventilation
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
On day 7 during mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
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
On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
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
On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
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)
On day 3, 5, 10, 14, 21 during mechanical ventilation
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)
On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Andrey I Yaroshetskiy, Dr.Med.Sc., Sechenov University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ACTUAL)

August 14, 2020

Study Completion (ACTUAL)

August 14, 2020

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (ACTUAL)

June 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-VENT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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