Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
NCT05963945
Atelectasis, Cardiomegaly
Havířov, Czechia
View Trial DetailsNCT Number: NCT04897152
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.
Looking for future studies?
Notify Me18 year–99 year
All sexes
Observational
Policlinico S.Orsola-Malpighi, Pneumologia e Terapia Intensiva Respiratoria, Bologna, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: February 20, 2020 - March 31, 2021
Effect of the different respiratory support strategies on barotrauma (pneumomediastinum and/or pneumothorax) occurrence
Time frame: February 20, 2020 - March 31, 2021
Estimating pneumomediastinum and pneumothorax frequency rates in hospitalized COVID-19 patients
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
Time frame: 30 days
Assessment of the in-hospital outcome, intended as "survival days" in hospitalized COVID-19 patients who manifest barotrauma
Azienda Sanitaria-Universitaria Integrata di Udine
Other
Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study
Acronym: COVI-MIX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT05963945
Atelectasis, Cardiomegaly
Havířov, Czechia
View Trial DetailsNCT03098524
Atelectasis, Bleeding
Neuilly-sur-Seine, Île-de-France Region, France
View Trial DetailsNCT06075836
Atelectasis, Bronchial Diseases
Oxford, Oxfordshire, United Kingdom
View Trial DetailsNCT04630301
Pleural Diseases, Pneumothorax
Baltimore, Maryland, United States
View Trial Details