跳至主要内容
临床试验/NCT04897152
NCT04897152已完成不适用

Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study

Azienda Sanitaria-Universitaria Integrata di Udine27 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2021年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
27
主要终点
Barotrauma occurrence with different respiratory strategies

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years of age or older hospitalized with SARS-COV2 infection

排除标准

  • Failure to obtain clinical or radiological information about the case

结局指标

主要结局

Barotrauma occurrence with different respiratory strategies

时间窗: February 20, 2020 - March 31, 2021

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

次要结局

  • Pneumomediastinum and pneumothorax(February 20, 2020 - March 31, 2021)
  • Risk factors other than ventilation strategy(February 20, 2020 - March 31, 2021)
  • 30-day outcome(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luigi Vetrugno

Clinical Professor in Anesthesiology and Intensive Care

Azienda Sanitaria-Universitaria Integrata di Udine

研究点 (27)

Loading locations...

相似试验