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Coronavirus Associated Pneumomediastinum and Pneumothorax

Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04897152
Acronym
COVI-MIX
Enrollment
241
Registered
2021-05-21
Start date
2021-08-15
Completion date
2021-08-31
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia, Pneumomediastinum, Pneumothorax

Brief summary

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.

Interventions

None listed

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Barotrauma occurrence with different respiratory strategiesFebruary 20, 2020 - March 31, 2021Effect of the different respiratory support strategies on barotrauma (pneumomediastinum and/or pneumothorax) occurrence

Secondary

MeasureTime frameDescription
Pneumomediastinum and pneumothoraxFebruary 20, 2020 - March 31, 2021Estimating pneumomediastinum and pneumothorax frequency rates in hospitalized COVID-19 patients
Risk factors other than ventilation strategyFebruary 20, 2020 - March 31, 2021Evaluating risk factors associated with barotrauma (spontaneous breathing, non-invasive, invasive, or extracorporeal circulation) in hospitalized COVID-19 patients
30-day outcome30 daysAssessment of the in-hospital outcome, intended as survival days in hospitalized COVID-19 patients who manifest barotrauma

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026