Coronavirus Associated Pneumomediastinum and Pneumothorax (COVI-MIX)

April 10, 2022 updated by: Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Policlinico S.Orsola-Malpighi, Pneumologia e Terapia Intensiva Respiratoria
      • Bologna, Italy
        • Policlinico S.Orsola-Malpighi, U.O Malattie Infettive
      • Catania, 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
      • Cuneo, Italy
        • Azienda Ospedaliera S.Croce e Carle Cuneo, SC Malattie Infettive e tropicali,
      • Genova, Italy
        • Ospedale Policlinico San Martino-IRCCS, Clinica di Malattie Infettive e Tropicali
      • Milano, Italy
        • Fondazione IRCCS, Ca Granda Ospedale Maggiore Policlinico, UOC, Malattie Infettive
      • Napoli, Italy
        • Ospedale dei colli, Malattie Infettive ed Urgenze Infettivologiche,
      • Padova, 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,
      • Palermo, Italy
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo, UOC Anestesia Rianimazione con Terapia Intensiva Polivalente e del Dolore
      • Parma, Italy
        • Azienda Ospedaliero-universitaria di Parma, Clinica pneumologica
      • Perugia, Italy
        • Azienda Ospedaliera Perugia, Malattie Infettive
      • Pontedera, Italy
        • Azienda USL Toscana Ovest, Ospedale Felice Lotti SOC Medicina Interna
      • Pordenone, Italy
        • Azienda Sanitaria Universitaria Friuli Occidentale, S.C Pneumologia
      • Torino, 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
      • Trieste, Italy
        • Azienda Sanitaria Universitaria Giuliano Isontina, S.C Pneumologia
      • Udine, Italy, 33100
        • 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
      • Vercelli, Italy
        • Azienda Sanitaria locale di Vercelli, Malattie infettive
      • Verona, Italy
        • Università di Verona, Clinica delle Malattie Infettive e Tropicali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients with SARS-COV2 infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Barotrauma occurrence with different respiratory strategies
Time Frame: February 20, 2020 - March 31, 2021
Effect of the different respiratory support strategies on barotrauma (pneumomediastinum and/or pneumothorax) occurrence
February 20, 2020 - March 31, 2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pneumomediastinum and pneumothorax
Time Frame: February 20, 2020 - March 31, 2021
Estimating pneumomediastinum and pneumothorax frequency rates in hospitalized COVID-19 patients
February 20, 2020 - March 31, 2021
Risk factors other than ventilation strategy
Time Frame: February 20, 2020 - March 31, 2021
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
30-day outcome
Time Frame: 30 days
Assessment of the in-hospital outcome, intended as "survival days" in hospitalized COVID-19 patients who manifest barotrauma
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Sanitaria-Universitaria Integrata di Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVI-MIX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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