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AzTrials

PneumothoraxCOVI-MIXNCT04897152

Coronavirus Associated Pneumomediastinum and Pneumothorax

An observational study of Pneumothorax and Pneumomediastinum, run by Azienda Sanitaria-Universitaria Integrata di Udine at 27 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
241 participants
Where
27 sitesItaly
Study dates
15 Aug 2021to 31 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitalized patients with SARS-COV2 infection

Who may be able to join

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

Who cannot join

  • Failure to obtain clinical or radiological information about the case

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Italy27 sites

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

    Bologna

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

    Bologna

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

    Catania

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

    Catania

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

    Cuneo

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

    Genova

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

    Milan

  • Ospedale dei colli, Malattie Infettive ed Urgenze Infettivologiche,

    Naples

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

    Padova

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

    Padova

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

    Palermo

  • Azienda Ospedaliero-Universitaria di Parma, Clinica Pneumologica

    Parma

  • Azienda Ospedaliera Perugia, Malattie Infettive

    Perugia

  • Azienda USL Toscana Ovest, Ospedale Felice Lotti SOC Medicina Interna

    Pontedera

  • Azienda Sanitaria Universitaria Friuli Occidentale, S.C Pneumologia

    Pordenone

  • AOU Città della Salute e Scienza, SC Malattie Infettive

    Torino

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

    Torino

  • Ospedale Cardinal Massaia, SC Malattie Infettive

    Torino

  • Azienda Sanitaria Universitaria Giuliano Isontina, S.C Pneumologia

    Trieste

  • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

    Udine, 33100

  • Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 1

    Udine

  • Azienda ospedaliero universitaria Friuli Centrale, Anestesia e Rianimazione 2

    Udine

  • Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione

    Udine

  • Azienda Ospedaliero Universitaria Friuli Centrale, Malattie infettive

    Udine

  • Azienda Ospedaliero Universitaria Friuli Centrale, Pneumologia

    Udine

  • Azienda Sanitaria locale di Vercelli, Malattie infettive

    Vercelli

  • Università di Verona, Clinica delle Malattie Infettive e Tropicali

    Verona

Other trials in Italy

About this study

Official title: Coronavirus Associated Pneumomediastinum and Pneumothorax - COVIMIX Study

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.

Read more

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.

Medical subject headings
Pneumothorax, Mediastinal Emphysema

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Barotrauma occurrence with different respiratory strategies

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

    Measured: February 20, 2020 - March 31, 2021

Secondary outcomes (3)

  1. Pneumomediastinum and pneumothorax

    Estimating pneumomediastinum and pneumothorax frequency rates in hospitalized COVID-19 patients

    Measured: February 20, 2020 - March 31, 2021

  2. 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

    Measured: February 20, 2020 - March 31, 2021

  3. 30-day outcome

    Assessment of the in-hospital outcome, intended as "survival days" in hospitalized COVID-19 patients who manifest barotrauma

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start15 Aug 2021
  3. Primary completion30 Aug 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04897152
Sponsor's protocol ID
COVI-MIX
Acronym
COVI-MIX
Status last verified
Apr 2022
First submitted
18 May 2021
Last updated
15 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 6375617

  • 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.

    PubMed 32330274

  • 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.

    PubMed 32007143

  • 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.

    PubMed 32312571

  • 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.

    PubMed 32614258

  • 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.

    PubMed 36669936

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumothorax and Pneumomediastinum, run by Azienda Sanitaria-Universitaria Integrata di Udine at 27 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Barotrauma occurrence with different respiratory strategies (time frame: February 20, 2020 - March 31, 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04897152, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.

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