COVID-19NCT05877443
Barotrauma in Adults With Critical COVID-19
An observational study of COVID-19 and Barotrauma, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Barotrauma
- What is being tested?
- Open system, Non-invasive mechanical ventilation and Invasive mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 669 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 29 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with critical COVID-19 admitted to an intensive care unit at Södersjukhuset, Stockholm, Sweden, March 2020 to May 2021.
Who may be able to join
- Positive polymerase chain reaction for SARS-CoV-2
- Admitted to ICU due to respiratory failure
Who cannot join
- Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Open system, Non-invasive mechanical ventilation, Invasive mechanical ventilation
- Medical subject headings
- COVID-19, Barotrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open systemProcedure or surgery
Oxygen delivered on open system, for example high flow nasal cannula or low flow oxygen by nasal cannula or face mask
Non-invasive mechanical ventilationProcedure or surgery
Respiratory support by for example continues or bilevel positive airway pressure
Invasive mechanical ventilationProcedure or surgery
Respiratory support delivered through endotracheal tube or tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Respiratory support by an open system | Not described Receives: Procedure: Open system | |
| Respiratory support by non-invasive mechanical ventilation | Not described Receives: Procedure: Non-invasive mechanical ventilation | |
| Respiratory support by invasive mechanical ventilation | Not described Receives: Procedure: Invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barotrauma
Pneumothorax, pneumomediastinum, pneumatocele or subcutaneous emphysema as verified by radiology
Measured: 28 days from ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Mar 2020
- Primary completion31 May 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Jonmarker, Karolinska Institutet
- Investigators
- Sandra Jonmarker, Ph D, Principal investigator, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877443
- Sponsor's protocol ID
- Barotrauma COVID-19
- Status last verified
- May 2023
- First submitted
- 25 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participants data for our patients is protected by law and can therefore not be made available for other researchers.
Publications
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.
PubMed 39936659
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barotrauma in Adults With Critical COVID-19
- ClinicalTrials.gov ID
- NCT05877443
- Acronym / sponsor ID
- Barotrauma COVID-19
- Conditions
- COVID-19, Barotrauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with critical COVID-19 admitted to an intensive care unit at Södersjukhuset, Stockholm, Sweden, March 2020 to May 2021.
Key inclusion criteria (2 listed)
- Positive polymerase chain reaction for SARS-CoV-2
- Admitted to ICU due to respiratory failure
Key exclusion criteria (1 listed)
- Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open systemOxygen delivered on open system, for example high flow nasal cannula or low flow oxygen by nasal cannula or face mask | Procedure or surgery | Respiratory support by an open system |
| Non-invasive mechanical ventilationRespiratory support by for example continues or bilevel positive airway pressure | Procedure or surgery | Respiratory support by non-invasive mechanical ventilation |
| Invasive mechanical ventilationRespiratory support delivered through endotracheal tube or tracheostomy | Procedure or surgery | Respiratory support by invasive mechanical ventilation |
Primary outcome
Barotrauma
Time frame: 28 days from ICU admission
Pneumothorax, pneumomediastinum, pneumatocele or subcutaneous emphysema as verified by radiology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Derived from this study: PubMed 39936659Jensen 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.
- Individual participant dataSharing planned: No. Individual participants data for our patients is protected by law and can therefore not be made available for other researchers.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Jonmarker, Ph D principal investigator
Stockholm South General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Barotrauma, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barotrauma (time frame: 28 days from ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.