Risk Factors for Barotrauma in COVID-19

Sponsor
Hospital General Ajusco Medio (Other)
Overall Status
Completed
CT.gov ID
NCT04859881
Collaborator
Horacio Marquez-Gonzalez (Other), Carlos Torruco-Sotelo (Other), Sebastian Rodriguez-Llamazares (Other)
262
1
10
26.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
262 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Risk Factors Associated With Barotrauma in COVID-19 Patients
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Barotrauma/cases

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

Other: No intervention
No intervention

No braotruma/Controls

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

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Mortality [During patient hospitalization, an average of one month]

    Dead of patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital General Ajusco Medio Mexico city Mexico 14250

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karla VerĂ³nica Chavez-Tostado, Head of Surgery Department, Hospital General Ajusco Medio
ClinicalTrials.gov Identifier:
NCT04859881
Other Study ID Numbers:
  • HGAM01
First Posted:
Apr 26, 2021
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karla VerĂ³nica Chavez-Tostado, Head of Surgery Department, Hospital General Ajusco Medio
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2021