Risk Factors for Barotrauma in COVID-19

Covid19 Clinical Trial

Official title:

Risk Factors Associated With Barotrauma in COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859881
• Other study ID #: HGAM01
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Barotrauma
• Covid19

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