Risk Factors for Barotrauma in COVID-19

Completed

• Conditions: Barotrauma; Covid19
• Interventions: Other: No intervention

• Registration Number: NCT04859881
• Lead Sponsor: Hospital General Ajusco Medio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-04
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-21
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Barotrauma/cases	No intervention	Cases were defined as patients with barotrauma consulted with the Surgery Department
No braotruma/Controls	No intervention	Controls were selected from a random sample of the COVID-19-ARDS cohort.

Primary Outcome Measures

Name	Time	Method
Barotrauma development	During patient hospitalization, an average of one month	Diagnosis of barotrauma in patients under mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome

Secondary Outcome Measures

Name	Time	Method
Mortality	During patient hospitalization, an average of one month	Dead of patient

Trial Locations

Locations (1)

Hospital General Ajusco Medio; 🇲🇽 Mexico city, Mexico