Barotrauma in Adults With Critical COVID-19

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT05877443
• Collaborator: (none)
• Enrollment: 669
• Location: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 37.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Barotrauma	Procedure: Open system; Procedure: Non-invasive mechanical ventilation; Procedure: Invasive mechanical ventilation

Study Design

• Study Type: Observational
• Actual Enrollment: 669 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Barotrauma in Adults With Critical COVID-19
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: Aug 29, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Barotrauma [28 days from ICU admission]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Södersjukhuset	Stockholm		Sweden	11883

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Sandra Jonmarker, Ph D, Stockholm South General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sandra Jonmarker, Consultant in intensive care and anaesthesia, Ph D, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT05877443
• Other Study ID Numbers: Barotrauma COVID-19
• First Posted: May 26, 2023
• Last Update Posted: May 30, 2023
• Last Verified: May 1, 2023

• 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
• Additional relevant MeSH terms: COVID-19; Barotrauma

Study Results

No Results Posted as of May 30, 2023