Coronavirus Associated Pneumomediastinum and Pneumothorax

COVID-19 Pneumonia Clinical Trial

— COVI-MIX  

Official title:

Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897152
• Other study ID #: COVI-MIX
• Status: Completed
• Start date: August 15, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2022
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: August 31, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumomediastinum
• Pneumothorax

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi, Pneumologia e Terapia Intensiva Respiratoria	Bologna
Italy	Policlinico S.Orsola-Malpighi, U.O Malattie Infettive	Bologna
Italy	Azienda Ospedaliero-Universitaria V.Emanuele Ferrarotto, S.bambino, Malattie Infettive	Catania
Italy	Azienda Ospedaliero-Universitaria V.Emanuele Ferrarotto, S.bambino, U.O.C. di Malattie Infettive	Catania
Italy	Azienda Ospedaliera S.Croce e Carle Cuneo, SC Malattie Infettive e tropicali,	Cuneo
Italy	Ospedale Policlinico San Martino-IRCCS, Clinica di Malattie Infettive e Tropicali	Genova
Italy	Fondazione IRCCS, Ca Granda Ospedale Maggiore Policlinico, UOC, Malattie Infettive	Milano
Italy	Ospedale dei colli, Malattie Infettive ed Urgenze Infettivologiche,	Napoli
Italy	Azienda Ospedaliera di Padova, S.C di Fisiopatologia respiratoria,	Padova
Italy	Unità Operativa Complessa Istituto di Anestesia e Rianimazione dell'Azienda Ospedale-Università di Padova,	Padova
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo, UOC Anestesia Rianimazione con Terapia Intensiva Polivalente e del Dolore	Palermo
Italy	Azienda Ospedaliero-Universitaria di Parma, Clinica Pneumologica	Parma
Italy	Azienda Ospedaliera Perugia, Malattie Infettive	Perugia
Italy	Azienda USL Toscana Ovest, Ospedale Felice Lotti SOC Medicina Interna	Pontedera
Italy	Azienda Sanitaria Universitaria Friuli Occidentale, S.C Pneumologia	Pordenone
Italy	AOU Città della Salute e Scienza, SC Malattie Infettive	Torino
Italy	Azienda Ospedaliera Ordine Mauriziano S.C. Pneumologia e Unità di Terapia Semi Intensiva Respiratoria	Torino
Italy	Ospedale Cardinal Massaia, SC Malattie Infettive	Torino
Italy	Azienda Sanitaria Universitaria Giuliano Isontina, S.C Pneumologia	Trieste
Italy	Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD	Udine
Italy	Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 1	Udine
Italy	Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 2	Udine
Italy	Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione	Udine
Italy	Azienda Ospedaliero Universitaria Friuli Centrale, Malattie infettive	Udine
Italy	Azienda Ospedaliero Universitaria Friuli Centrale, Pneumologia	Udine
Italy	Azienda Sanitaria locale di Vercelli, Malattie infettive	Vercelli
Italy	Università di Verona, Clinica delle Malattie Infettive e Tropicali	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. — View Citation

Maunder RJ, Pierson DJ, Hudson LD. Subcutaneous and mediastinal emphysema. Pathophysiology, diagnosis, and management. Arch Intern Med. 1984 Jul;144(7):1447-53. Review. — View Citation

McGuinness G, Zhan C, Rosenberg N, Azour L, Wickstrom M, Mason DM, Thomas KM, Moore WH. Increased Incidence of Barotrauma in Patients with COVID-19 on Invasive Mechanical Ventilation. Radiology. 2020 Nov;297(2):E252-E262. doi: 10.1148/radiol.2020202352. Epub 2020 Jul 2. — View Citation

Wang W, Gao R, Zheng Y, Jiang L. COVID-19 with spontaneous pneumothorax, pneumomediastinum and subcutaneous emphysema. J Travel Med. 2020 Aug 20;27(5). pii: taaa062. doi: 10.1093/jtm/taaa062. — View Citation

Yao W, Wang T, Jiang B, Gao F, Wang L, Zheng H, Xiao W, Yao S, Mei W, Chen X, Luo A, Sun L, Cook T, Behringer E, Huitink JM, Wong DT, Lane-Fall M, McNarry AF, McGuire B, Higgs A, Shah A, Patel A, Zuo M, Ma W, Xue Z, Zhang LM, Li W, Wang Y, Hagberg C, O'Sullivan EP, Fleisher LA, Wei H; collaborators. Emergency tracheal intubation in 202 patients with COVID-19 in Wuhan, China: lessons learnt and international expert recommendations. Br J Anaesth. 2020 Jul;125(1):e28-e37. doi: 10.1016/j.bja.2020.03.026. Epub 2020 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pneumomediastinum and pneumothorax	Estimating pneumomediastinum and pneumothorax frequency rates in hospitalized COVID-19 patients	February 20, 2020 - March 31, 2021
Secondary	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
Secondary	30-day outcome	Assessment of the in-hospital outcome, intended as "survival days" in hospitalized COVID-19 patients who manifest barotrauma	30 days