Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-28 @ 6:18 PM
Study NCT ID:
NCT04445961
Status:
COMPLETED
Last Update Posted:
2020-08-27
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure
Sponsor:
I.M. Sechenov First Moscow State Medical University
Organization:
Study Overview
Official Title:
Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-VENT
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: