Risk Factors for Barotrauma in COVID-19

NCT04859881 | Completed

• 1 other identifier: HGAM01
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Barotrauma; Covid19

Keywords

Barotrauma; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mortality

  During patient hospitalization, an average of one month

Study Arms (2)

Barotrauma/cases

Cases were defined as patients with barotrauma consulted with the Surgery Department

Other: No intervention

No braotruma/Controls

Controls were selected from a random sample of the COVID-19-ARDS cohort.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Barotrauma/cases; No braotruma/Controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of severe SARS-COV2 infection and mechanical ventilation, admitted in a single-center community Hospital in Mexico City.

You may qualify if:

• Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction

You may not qualify if:

• Incomplete clinical records and other causes of extrapulmonary air

Sponsors & Collaborators

• Hospital General Ajusco Medio: lead
• Horacio Marquez-Gonzalez: collaborator
• Carlos Torruco-Sotelo: collaborator
• Sebastian Rodriguez-Llamazares: collaborator

Study Sites (1)

Hospital General Ajusco Medio

Mexico City, 14250, Mexico

Location

MeSH Terms

Conditions

Barotrauma; COVID-19

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery Department

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 26, 2021
• Study Start: April 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)