BarotraumaNCT04859881
Risk Factors for Barotrauma in COVID-19
An observational study of Barotrauma and Covid19, run by Hospital General Ajusco Medio at 1 site in Mexico.
Trial summary
Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (VILI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Barotrauma, Covid19
- How many people
- 262 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2020to 31 Jan 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of severe SARS-COV2 infection and mechanical ventilation, admitted in a single-center community Hospital in Mexico City.
Who may be able to join
- Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction
Who cannot join
- Incomplete clinical records and other causes of extrapulmonary air
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors Associated With Barotrauma in COVID-19 Patients
Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (VILI). Previous studies have shown an increased mortality in patients with barotrauma under MV; pneumothorax (PTX) being the most common presentation, but it can also present as pneumomediastinum (PM) with or without PTX, with extension to soft tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum.
Traditionally, underlying lung disease or age are known risk factors for non-trauma related barotrauma. However, in patients with novel coronavirus disease (COVID-19), the incidence of this complication is more common than in non-infected patients, as recently reported. Since little is known regarding which are the main risk factors for these events to develop, most pathophysiological mechanisms remain unexplained.
The aim of this study was to determine the risk factors for developing barotrauma in patients under MV with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Secondary objectives were to determine the incidence of barotrauma and its association with mortality.
- Conditions
- Barotrauma, Covid19
- Being tested
- No intervention
- Keywords
- Barotrauma, COVID-19
- Medical subject headings
- Barotrauma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Barotrauma/cases | Cases were defined as patients with barotrauma consulted with the Surgery Department Receives: Other: No intervention | |
| No braotruma/Controls | Controls were selected from a random sample of the COVID-19-ARDS cohort. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barotrauma development
Diagnosis of barotrauma in patients under mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome
Measured: During patient hospitalization, an average of one month
Secondary outcomes (1)
Mortality
Dead of patient
Measured: During patient hospitalization, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BarotraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Ajusco Medio
- Sponsor type
- University, hospital or other
- Collaborators
- Horacio Marquez-Gonzalez, Carlos Torruco-Sotelo, Sebastian Rodriguez-Llamazares
- Responsible party
- Principal investigator, Karla Verónica Chavez-Tostado, Hospital General Ajusco Medio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859881
- Sponsor's protocol ID
- HGAM01
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated With Barotrauma in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04859881
- Acronym / sponsor ID
- HGAM01
- Conditions
- Barotrauma, Covid19
- Keywords
- Barotrauma, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Hospital General Ajusco MedioUniversity, hospital or other
- Collaborators
- Horacio Marquez-Gonzalez, Carlos Torruco-Sotelo, Sebastian Rodriguez-Llamazares
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (VILI). Previous studies have shown an increased mortality in patients with barotrauma under MV; pneumothorax (PTX) being the most common presentation, but it can also present as pneumomediastinum (PM) with or without PTX, with extension to soft tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum.
Traditionally, underlying lung disease or age are known risk factors for non-trauma related barotrauma. However, in patients with novel coronavirus disease (COVID-19), the incidence of this complication is more common than in non-infected patients, as recently reported. Since little is known regarding which are the main risk factors for these events to develop, most pathophysiological mechanisms remain unexplained.
The aim of this study was to determine the risk factors for developing barotrauma in patients under MV with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Secondary objectives were to determine the incidence of barotrauma and its association with mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barotrauma/cases | – | Other: No interventionCases were defined as patients with barotrauma consulted with the Surgery Department |
| No braotruma/Controls | – | Other: No interventionControls were selected from a random sample of the COVID-19-ARDS cohort. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of severe SARS-COV2 infection and mechanical ventilation, admitted in a single-center community Hospital in Mexico City.
Key inclusion criteria (1 listed)
- Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction
Key exclusion criteria (1 listed)
- Incomplete clinical records and other causes of extrapulmonary air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Barotrauma/cases, No braotruma/Controls |
Primary outcome
Barotrauma development
Time frame: During patient hospitalization, an average of one month
Diagnosis of barotrauma in patients under mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome
1 secondary outcome
Mortality
Time frame: During patient hospitalization, an average of one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barotrauma and Covid19, run by Hospital General Ajusco Medio at 1 site in Mexico.
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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 development (time frame: During patient hospitalization, an average of one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.