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Completed

NCT Number: NCT04897152

Coronavirus Associated Pneumomediastinum and Pneumothorax

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico S.Orsola-Malpighi, Pneumologia e Terapia Intensiva Respiratoria, Bologna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Barotrauma occurrence with different respiratory strategies

    Time frame: February 20, 2020 - March 31, 2021

    Effect of the different respiratory support strategies on barotrauma (pneumomediastinum and/or pneumothorax) occurrence

Secondary outcomes

  1. Pneumomediastinum and pneumothorax

    Time frame: February 20, 2020 - March 31, 2021

    Estimating pneumomediastinum and pneumothorax frequency rates in hospitalized COVID-19 patients

  2. Risk factors other than ventilation strategy

    Time frame: February 20, 2020 - March 31, 2021

    Evaluating risk factors associated with barotrauma (spontaneous breathing, non-invasive, invasive, or extracorporeal circulation) in hospitalized COVID-19 patients

  3. 30-day outcome

    Time frame: 30 days

    Assessment of the in-hospital outcome, intended as "survival days" in hospitalized COVID-19 patients who manifest barotrauma

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Other

Registry information

Official study title

Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study

Acronym: COVI-MIX

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 21, 2021
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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