Barotrauma in Adults With Critical COVID-19

Completed

• Conditions: COVID-19; Barotrauma
• Interventions: Procedure: Non-invasive mechanical ventilation; Procedure: Open system; Procedure: Invasive mechanical ventilation

• Registration Number: NCT05877443
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-08-29
• Status Verified: 2023-05
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 669

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Respiratory support by non-invasive mechanical ventilation	Non-invasive mechanical ventilation	-
Respiratory support by an open system	Open system	-
Respiratory support by invasive mechanical ventilation	Invasive mechanical ventilation	-

Primary Outcome Measures

Name	Time	Method
Barotrauma	28 days from ICU admission	Pneumothorax, pneumomediastinum, pneumatocele or subcutaneous emphysema as verified by radiology

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden