Barotrauma in Adults With Critical COVID-19

NCT05877443 | Completed

• 1 other identifier: Barotrauma COVID-19
• Study Type: observational
• Target: 669
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Barotrauma

Outcome Measures

Primary Outcomes (1)

• Barotrauma

  Pneumothorax, pneumomediastinum, pneumatocele or subcutaneous emphysema as verified by radiology

  28 days from ICU admission

Study Arms (3)

Respiratory support by an open system

Procedure: Open system

Respiratory support by non-invasive mechanical ventilation

Procedure: Non-invasive mechanical ventilation

Respiratory support by invasive mechanical ventilation

Procedure: Invasive mechanical ventilation

Interventions

Open system PROCEDURE

Oxygen delivered on open system, for example high flow nasal cannula or low flow oxygen by nasal cannula or face mask

Respiratory support by an open system

Non-invasive mechanical ventilation PROCEDURE

Respiratory support by for example continues or bilevel positive airway pressure

Respiratory support by non-invasive mechanical ventilation

Invasive mechanical ventilation PROCEDURE

Respiratory support delivered through endotracheal tube or tracheostomy

Respiratory support by invasive mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (1)

• Jensen AL, Litorell J, Grip J, Dahlberg M, Joelsson-Alm E, Jonmarker S. A descriptive, retrospective single-centre study of air-leak syndrome in intensive care unit patients with COVID-19. Acta Anaesthesiol Scand. 2025 Mar;69(3):e14582. doi: 10.1111/aas.14582.

  PMID: 39936659 DERIVED

MeSH Terms

Conditions

COVID-19; Barotrauma

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Sandra Jonmarker, Ph D

  Stockholm South General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in intensive care and anaesthesia, Ph D

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: May 26, 2023
• Study Start: March 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: August 29, 2021
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)