ARDS Clinical Trial
Official title:
Ventilatory Efficiency in Critically Ill COVID-19 Patients
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 15, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: All of the following: - confirmed SARS-CoV-2 infection by RT-PCR on a nasopharyngeal swab - severe hypoxemia due to COVID-19 who meets the diagnostic criteria of ARDS (Berlin's definition) - invasive mechanical ventilation - patients receiving neuromuscular blocking drugs Exclusion Criteria: - history of preexisting severe hypoxemia (i.e. primary pulmonary hypertension, COPD in therapy with O2 supplementation, pulmonary fibrosis, etc.) - severe haemodynamic instability defined as: - Mean arterial pressure < 65 mmHg despite the infusion of norepinephrine, or epinephrine, or dobutamine, or levosimendan - severe left ventricular dysfunction with ejection fraction <20% - right ventricular failure due to pulmonary embolism |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti | Ancona | Marche |
Italy | Arcispedale Sant'Anna | Ferrara | Emilia Romagna |
Italy | ASST Fatebenefratelli Sacco | Milan | Lombardy |
Italy | Ospedale Infermi | Rimini | Emilia Romagna |
Lead Sponsor | Collaborator |
---|---|
ASST Fatebenefratelli Sacco | Azienda Ospedaliero, Universitaria Ospedali Riuniti, Ospedale Infermi Rimini, S. Anna Hospital |
Italy,
ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. — View Citation
Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC. — View Citation
WHO Weekly epidemiological update - 29 December 2020 - https://www.who.int/publications/m/item/weekly-epidemiological-update---29-december-2020
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ventilatory ratio correlation | Measure the correlation between ventilatory ratio, plasma D-dimer, and quasi-static compliance of the respiratory system | 24 hours from ICU admission | |
Secondary | Mortality | Mortality among subgroups stratified according to Ventilatory ratio and quasi-static respiratory compliance. Subgroup will be identified according centiles of the distribution values of 1) Ventilatory Ratio, and 2) quasi-static compliance both measured in the first 24 hours. | 30 days |
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