Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ospedale Infermi Rimini | UNKNOWN |
| S. Anna Hospital | OTHER |
| Azienda Ospedaliero, Universitaria Ospedali Riuniti | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARDS COVID-19 | Patients who meet Berlin's ARDS diagnostic criteria, with confirmed SARS-CoV-2 infection, requiring invasive mechanical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data collecting | Other | Within 24h from ICU admission, the ventilatory efficiency will be assessed by the following Ventilatory Ratio equation: Ventilatory Ratio = [minute ventilation (ml/min) × PaCO2 (mm Hg)]/(predicted body weight × 100 × 37.5). Where PaCO2 is the partial pressure of carbon dioxide in mmHg in the arterial blood. Tha quasi-static compliance will be calculated according to the equation: C=Tidal Volume/(Paw plateau - PEEP total) where Paw plateau is the airway pressure measured during 4 seconds of inspiratory pause, PEEP total is the airway pressure measured during 4 seconds of expiratory pause. In the same time frame, complete blood count, d-dimer, sequential organ failure assessment score, blood gas analysis, haemodynamic and ventilatory parameters will be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
All of the following:
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:
Not provided
Not provided
All patients consecutively admitted to ICU with the eligibility criteria will be enrolled in the study. They will be treated according to the standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riccardo Colombo, M.D. | Contact | +390239043023 | riccardo.colombo@asst-fbf-sacco.it | |
| Andrea Agarossi, M.D. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Riccardo Colombo, M.D. | ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcispedale Sant'Anna | Not yet recruiting | Ferrara | Emilia-Romagna | 44124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO Weekly epidemiological update - 29 December 2020 - https://www.who.int/publications/m/item/weekly-epidemiological-update---29-december-2020 | ||
| 30211618 | Background | 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. | |
| 22797452 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ospedale Infermi | Not yet recruiting | Rimini | Emilia-Romagna | 47923 | Italy |
|
| ASST Fatebenefratelli Sacco | Recruiting | Milan | Lombardy | 20157 | Italy |
|
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Recruiting | Ancona | The Marches | 60126 | Italy |
|
| Background |
| 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |