NCT04694742

Ventilatory Efficiency in Critically Ill COVID-19 Patients

Status unknown Last updated 5 January 2021

What this trial tests

trial testing data collecting in ARDS in 100 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
31 March 2021

15 April 2021

Quick facts

Lead sponsor	ASST Fatebenefratelli Sacco
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 September 2020
Primary completion	31 March 2021
Estimated completion	15 April 2021
Sites	4 locations across Italy

Drugs / interventions tested

• data collecting

Conditions studied

• ARDS — all drugs for ARDS →

Sponsor

ASST Fatebenefratelli Sacco — full company profile →

Who can join

Adults 18 to 90, any sex, with ARDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The new severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2) causes the illness named COVID-19, which is primarily characterized by pneumonia. As of 27 December, there have been over 79.2 million cases and over 1.7 million deaths reported since the start of the pandemic. In many cases, pneumonia evolves to acute respiratory distress syndrome (ARDS) with the need for mechanical ventilation and patient admission to intensive care unit, determining a marked increase in the need for intensive care beds worldwide.

Pulmonary involvement causes predominantly hypoxemic respiratory failure. Although COVID-19 pneumonia often falls within the diagnostic criteria of ARDS, it differs from it for some peculiar pathophysiological characteristics. In particular, patients with ARDS secondary to COVID-19 often have the compliance of the respiratory system within the normal range. A significant role in the pathophysiology of hypoxemia seems to depend on vascular alterations such as altered pulmonary vascular self-regulation, pulmonary capillary leakage, and microvascular thrombosis in a complex process known as "immunothrombosis". All together they act by altering the relationship between ventilation and perfusion and increasing the dead space, which ultimately results in impaired efficiency of the pulmonary ventilation. Among the various markers associated with the prognosis of patients with COVID-19, D-dimer is linked to both the inflammatory state and thrombotic phenomena and could help to identify patients at greater risk of developing early ventilation-perfusion changes.

This study aims at measuring the ventilatory efficiency, assessed by Ventilatory Ratio, in critically ill, mechanically ventilated, COVID-19 patients and its correlation with plasma D-dimer and quasi-static respiratory compliance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.