Clinical trial NCT04897152: Coronavirus Associated Pneumomediastinum and Pneumothorax
Official title: Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumothorax
Pneumomediastinum
COVID-19 Pneumonia
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with SARS-COV2 infection

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.


Eligibility criteria: 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

Primary outcomes:
measure: Barotrauma occurrence with different respiratory strategies
timeFrame: February 20, 2020 - March 31, 2021
Secondary outcomes:
measure: Pneumomediastinum and pneumothorax
timeFrame: February 20, 2020 - March 31, 2021
measure: Risk factors other than ventilation strategy
timeFrame: February 20, 2020 - March 31, 2021
measure: 30-day outcome
timeFrame: 30 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi, Pneumologia e Terapia Intensiva Respiratoria
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi, U.O Malattie Infettive
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria V.Emanuele Ferrarotto, S.bambino, Malattie Infettive
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria V.Emanuele Ferrarotto, S.bambino, U.O.C. di Malattie Infettive
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S.Croce e Carle Cuneo, SC Malattie Infettive e tropicali,
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino-IRCCS, Clinica di Malattie Infettive e Tropicali
city: Milano
country: Italy
facility: Fondazione IRCCS, Ca Granda Ospedale Maggiore Policlinico, UOC, Malattie Infettive
city: Napoli
country: Italy
facility: Ospedale dei colli, Malattie Infettive ed Urgenze Infettivologiche,
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova, S.C di Fisiopatologia respiratoria,
city: Padova
country: Italy
facility: Unità Operativa Complessa Istituto di Anestesia e Rianimazione dell'Azienda Ospedale-Università di Padova,
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo, UOC Anestesia Rianimazione con Terapia Intensiva Polivalente e del Dolore
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma, Clinica Pneumologica
city: Perugia
country: Italy
facility: Azienda Ospedaliera Perugia, Malattie Infettive
city: Pontedera
country: Italy
facility: Azienda USL Toscana Ovest, Ospedale Felice Lotti SOC Medicina Interna
city: Pordenone
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Occidentale, S.C Pneumologia
city: Torino
country: Italy
facility: AOU Città della Salute e Scienza, SC Malattie Infettive
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano S.C. Pneumologia e Unità di Terapia Semi Intensiva Respiratoria
city: Torino
country: Italy
facility: Ospedale Cardinal Massaia, SC Malattie Infettive
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina, S.C Pneumologia
city: Udine
country: Italy
facility: Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
city: Udine
country: Italy
facility: Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 1
city: Udine
country: Italy
facility: Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 2
city: Udine
country: Italy
facility: Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria Friuli Centrale, Malattie infettive
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria Friuli Centrale, Pneumologia
city: Vercelli
country: Italy
facility: Azienda Sanitaria locale di Vercelli, Malattie infettive
city: Verona
country: Italy
facility: Università di Verona, Clinica delle Malattie Infettive e Tropicali
Study officials:
References:
citation: Maunder RJ, Pierson DJ, Hudson LD. Subcutaneous and mediastinal emphysema. Pathophysiology, diagnosis, and management. Arch Intern Med. 1984 Jul;144(7):1447-53.
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):taaa062. doi: 10.1093/jtm/taaa062.
citation: 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.
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.
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.