Covid19 Clinical Trial
Official title:
Risk Factors Associated With Barotrauma in COVID-19 Patients
NCT number | NCT04859881 |
Other study ID # | HGAM01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | January 31, 2021 |
Verified date | April 2021 |
Source | Hospital General Ajusco Medio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 262 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction Exclusion Criteria: - Incomplete clinical records and other causes of extrapulmonary air |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital General Ajusco Medio | Mexico city |
Lead Sponsor | Collaborator |
---|---|
Hospital General Ajusco Medio | Carlos Torruco-Sotelo, Horacio Marquez-Gonzalez, Sebastian Rodriguez-Llamazares |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Barotrauma development | Diagnosis of barotrauma in patients under mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome | During patient hospitalization, an average of one month | |
Secondary | Mortality | Dead of patient | During patient hospitalization, an average of one month |
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