Barotrauma in Adults With Critical COVID-19

During the pandemic of COVID-19, studies reporting a high incidence of barotrauma, both pneumothorax but also pneumomediastinum, in patients with critical COVID-19. If this is complications of the respiratory support used to treat patients hypoxemia or if it is a direct consequence of COVID-19 damaging the lung tissue is not known.

The aim of this study is to investigate the incidence and type barotrauma, if there is an association between barotrauma and level of respiratory support used in the intensive care unit, and if barotrauma is associated with worse outcome compared to patients without barotrauma.

Study Overview

• Status: Completed
• Conditions: COVID-19; Barotrauma
• Intervention / Treatment: Procedure: Open system; Procedure: Non-invasive mechanical ventilation; Procedure: Invasive mechanical ventilation

• Study Type: Observational
• Enrollment (Actual): 669

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Södersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with critical COVID-19 admitted to an intensive care unit at Södersjukhuset, Stockholm, Sweden, March 2020 to May 2021.

Description

Inclusion Criteria:

• Positive polymerase chain reaction for SARS-CoV-2
• Admitted to ICU due to respiratory failure

Exclusion Criteria:

• Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Respiratory support by an open system	Procedure: Open system; Oxygen delivered on open system, for example high flow nasal cannula or low flow oxygen by nasal cannula or face mask
Respiratory support by non-invasive mechanical ventilation	Procedure: Non-invasive mechanical ventilation; Respiratory support by for example continues or bilevel positive airway pressure
Respiratory support by invasive mechanical ventilation	Procedure: Invasive mechanical ventilation; Respiratory support delivered through endotracheal tube or tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barotrauma	Pneumothorax, pneumomediastinum, pneumatocele or subcutaneous emphysema as verified by radiology	28 days from ICU admission

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Sandra Jonmarker, Ph D, Stockholm South General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): August 29, 2021

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Wounds and Injuries; COVID-19; Barotrauma
• Other Study ID Numbers: Barotrauma COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participants data for our patients is protected by law and can therefore not be made available for other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No