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COVI-MIX
Sponsor study identifier
observational
241
1 country
27
Study Start
August 15, 2021
Actual (reported)Primary Completion
August 30, 2021
Actual (reported)Study Completion
August 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 18, 2021
Actual (reported)May 21, 2021
Actual (reported)August 15, 2021
Actual (reported)August 30, 2021
Actual (reported)August 31, 2021
Actual (reported)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
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
Hospitalized patients with SARS-COV2 infection
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
Maunder RJ, Pierson DJ, Hudson LD. Subcutaneous and mediastinal emphysema. Pathophysiology, diagnosis, and management. Arch Intern Med. 1984 Jul;144(7):1447-53.
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.
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.
241 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2021
First Posted
May 21, 2021
Study Start
August 15, 2021
Actual (reported)Contact the study team to confirm eligibility.
Fondazione IRCCS, Ca Granda Ospedale Maggiore Policlinico, UOC, Malattie Infettive
Milan, Italy
Ospedale dei colli, Malattie Infettive ed Urgenze Infettivologiche,
Naples, 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, 33100, 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, Italy
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.
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.
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.
Primary Completion
August 30, 2021
Actual (reported)Study Completion
August 31, 2021
Actual (reported)Last Updated
April 15, 2022
Record last verified: 2022-04
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