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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2021
Source Hospital General Ajusco Medio
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Mexico Hospital General Ajusco Medio Mexico city

Sponsors (4)

Lead Sponsor Collaborator
Hospital General Ajusco Medio Carlos Torruco-Sotelo, Horacio Marquez-Gonzalez, Sebastian Rodriguez-Llamazares

Country where clinical trial is conducted

Mexico, 

Outcome

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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