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NCT05877443 Clinical Trial

Barotrauma in Adults With Critical COVID-19

COVID-19 Clinical Trial

Official title:
Barotrauma in Adults With Critical COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05877443
Other study ID # Barotrauma COVID-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date August 29, 2021

Study information
Verified date May 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 669
Est. completion date August 29, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden Södersjukhuset Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Barotrauma Pneumothorax, pneumomediastinum, pneumatocele or subcutaneous emphysema as verified by radiology 28 days from ICU admission
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