Coronavirus Associated Pneumomediastinum and Pneumothorax

Study Overview
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Brief Summary
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Spontaneous pneumomediastinum (PMS) is defined as free air within the mediastinum. Spontaneous pneumothorax (PNX) consists of the presence of air inside the pleural space. PMS and PNX may sometimes occur secondly to an underlying pathology, or deriving from a sudden increase in intra-alveolar pressure such as functional alteration such as airway hyperactivity, Valsalva maneuver, cough, barotrauma, and/or volutrauma with consequent rupture of the alveoli and subsequent leakage of air into the mediastinum due to the Macklin effect. The escaping air can then spread inside the pericardium, the peritoneum, the muscles, and subcutaneous tissues, hence causing subcutaneous emphysema. PMS and PNX are rare complications of several lung infections such as Pneumocystis Jirovecii pneumonia, tuberculosis, bacterial necrotizing pneumonia, and herpes pneumonia. However, an increasing number of PMS and PNX has been described in patients with SARS-CoV2 interstitial pneumonia. PMS and PNX can either present as the onset manifestation of COVID-19 disease, or occur as complications of non-invasive and/or invasive ventilation, or following to cystic and/or fibrotic evolution of the pathology. The frequency of PMS and PNX during COVID-19 is not well defined, as the available data are limited to case collections and single reports. According to currently available scientific literature, PNX in COVID-19 occurs with frequency rates of 1-3%, up to 6% in patients undergoing non-invasive ventilation (NIV) and mechanical artificial ventilation (VAM). In McGuinness's analysis, which compared the complications of barotrauma in patients with acute respiratory distress syndrome (ARDS) in VAM, PNX and PMS occurred with frequency rates of 9% and 10%, respectively, while in non-COVID-19 population, PNX and PMS frequency rates were 12% and 3%, respectively.

Official Title
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Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study

Conditions
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Pneumothorax, Pneumomediastinum, COVID-19 Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older hospitalized with SARS-COV2 infection Exclusion Criteria: Failure to obtain clinical or radiological information about the case

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barotrauma occurrence with different respiratory strategies | Effect of the different respiratory support strategies on barotrauma (pneumomediastinum and/or pneumothorax) occurrence | February 20, 2020 - March 31, 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumomediastinum and pneumothorax | Estimating pneumomediastinum and pneumothorax frequency rates in hospitalized COVID-19 patients | February 20, 2020 - March 31, 2021 | 
| Risk factors other than ventilation strategy | Evaluating risk factors associated with barotrauma (spontaneous breathing, non-invasive, invasive, or extracorporeal circulation) in hospitalized COVID-19 patients | February 20, 2020 - March 31, 2021 | 
| 30-day outcome | Assessment of the in-hospital outcome, intended as survival days in hospitalized COVID-19 patients who manifest barotrauma | 30 days |