Coronavirus Associated Pneumomediastinum and Pneumothorax

NCT04897152 | Completed

• 1 other identifier: COVI-MIX
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 27

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.

Conditions

Pneumothorax; Pneumomediastinum; COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with SARS-COV2 infection

You may qualify if:

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

You may not qualify if:

• Failure to obtain clinical or radiological information about the case

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (27)

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

Bologna, Italy

Location

Policlinico S.Orsola-Malpighi, U.O Malattie Infettive

Bologna, Italy

Location

Azienda Ospedaliero-Universitaria V.Emanuele Ferrarotto, S.bambino, Malattie Infettive

Catania, Italy

Location

Azienda Ospedaliero-Universitaria V.Emanuele Ferrarotto, S.bambino, U.O.C. di Malattie Infettive

Catania, Italy

Location

Azienda Ospedaliera S.Croce e Carle Cuneo, SC Malattie Infettive e tropicali,

Cuneo, Italy

Location

Ospedale Policlinico San Martino-IRCCS, Clinica di Malattie Infettive e Tropicali

Genova, Italy

Location

Fondazione IRCCS, Ca Granda Ospedale Maggiore Policlinico, UOC, Malattie Infettive

Milan, Italy

Location

Ospedale dei colli, Malattie Infettive ed Urgenze Infettivologiche,

Napoli, Italy

Location

Azienda Ospedaliera di Padova, S.C di Fisiopatologia respiratoria,

Padua, Italy

Location

Unità Operativa Complessa Istituto di Anestesia e Rianimazione dell'Azienda Ospedale-Università di Padova,

Padua, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo, UOC Anestesia Rianimazione con Terapia Intensiva Polivalente e del Dolore

Palermo, Italy

Location

Azienda Ospedaliero-Universitaria di Parma, Clinica Pneumologica

Parma, Italy

Location

Azienda Ospedaliera Perugia, Malattie Infettive

Perugia, Italy

Location

Azienda USL Toscana Ovest, Ospedale Felice Lotti SOC Medicina Interna

Pontedera, Italy

Location

Azienda Sanitaria Universitaria Friuli Occidentale, S.C Pneumologia

Pordenone, Italy

Location

AOU Città della Salute e Scienza, SC Malattie Infettive

Torino, Italy

Location

Azienda Ospedaliera Ordine Mauriziano S.C. Pneumologia e Unità di Terapia Semi Intensiva Respiratoria

Torino, Italy

Location

Ospedale Cardinal Massaia, SC Malattie Infettive

Torino, Italy

Location

Azienda Sanitaria Universitaria Giuliano Isontina, S.C Pneumologia

Trieste, Italy

Location

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Location

Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 1

Udine, Italy

Location

Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 2

Udine, Italy

Location

Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione

Udine, Italy

Location

Azienda Ospedaliero Universitaria Friuli Centrale, Malattie infettive

Udine, Italy

Location

Azienda Ospedaliero Universitaria Friuli Centrale, Pneumologia

Udine, Italy

Location

Azienda Sanitaria locale di Vercelli, Malattie infettive

Vercelli, Italy

Location

Università di Verona, Clinica delle Malattie Infettive e Tropicali

Verona, Italy

Location

Related Publications (6)

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

  PMID: 6375617 BACKGROUND

• 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.

  PMID: 32330274 BACKGROUND

• 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.

  PMID: 32007143 BACKGROUND

• 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.

  PMID: 32312571 BACKGROUND

• 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.

  PMID: 32614258 BACKGROUND

• Vetrugno L, Castaldo N, Fantin A, Deana C, Cortegiani A, Longhini F, Forfori F, Cammarota G, Grieco DL, Isola M, Navalesi P, Maggiore SM, Bassetti M, Chetta A, Confalonieri M, De Martino M, Ferrari G, Francisi D, Luzzati R, Meini S, Scozzafava M, Sozio E, Tascini C, Bassi F, Patruno V; Italian COVI-MIX Study Group; De Robertis E, Aldieri C, Ball L, Baratella E, Bartoletti M, Boscolo A, Burgazzi B, Catalanotti V, Confalonieri P, Corcione S, De Rosa FG, De Simoni A, Bono VD, Tria RD, Forlani S, Giacobbe DR, Granozzi B, Labate L, Lococo S, Lupia T, Matellon C, Mehrabi S, Morosi S, Mongodi S, Mura M, Nava S, Pol R, Pettenuzzo T, Quyen NH, Rescigno C, Righi E, Ruaro B, Salton F, Scabini S, Scarda A, Sibani M, Tacconelli E, Tartaglione G, Tazza B, Vania E, Viale P, Vianello A, Visentin A, Zuccon U, Meroi F, Buonsenso D. Ventilatory associated barotrauma in COVID-19 patients: A multicenter observational case control study (COVI-MIX-study). Pulmonology. 2023 Nov-Dec;29(6):457-468. doi: 10.1016/j.pulmoe.2022.11.002. Epub 2022 Nov 24.

  PMID: 36669936 DERIVED

MeSH Terms

Conditions

Pneumothorax; Mediastinal Emphysema

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Mediastinal Diseases; Thoracic Diseases; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: August 15, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 31, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

IT (27)