ARDS Due to COVID-19NCT05102630
Ventilator Strategies in ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.
An observational study of ARDS Due to COVID-19, run by University of Southern Denmark at 2 sites in Denmark.
Trial summary
Mechanical ventilation is likely lifesaving in patients with coronavirus disease 2019 (COVID-19) but may also result in adverse events. Only few studies describe the strategies used and adverse effect of mechanical ventilation in an unselected population of ICU patients with COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ARDS Due to COVID-19
- How many people
- 1,193 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jun 2021to Apr 2022
- How long will I take part?
- 90 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All mechanical ventilated patients registered in the national Danish COVID ICU database
Who may be able to join
- All mechanical ventilated patients registered in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e.
- Admitted to an ICU in Denmark
- Laboratory-confirmed SARS-CoV-2 infection
- Use of invasive mechanical ventilation (ventilation via a cuffed endotracheal tube) at any time during the ICU stay
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Nikolai arnold-larsen, MD contact
Denmark2 sites, 2 recruiting
- Recruiting
Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital
Aalborg, 9000
Frederik Nielsen, MD, (+45) 97 66 19 24, frederik.nielsen@rn.dk
- Recruiting
Department of Anesthesiology and Intensive Care, Kolding Hospital
Kolding, 6000
Anne C Brøchner, MD, Ph D, 29464468, anne.craveiro.broechner@rsyd.dk
About this study
Official title: The Use of Mechanical Ventilation Strategies and Its Potential Adverse Events Among ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.
Mechanical ventilation is likely lifesaving in patients with coronavirus disease 2019 (COVID-19) but may also result in adverse events. Only few studies describe the strategies used and adverse effect of mechanical ventilation in an unselected population of ICU patients with COVID-19.
This study is designed to be a retrospective study focusing on all mechanical ventilated ICU patients with COVID-19 included in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e. a total of 1,193 patients. The investigators will register the use of the core interventions around mechanical ventilation and its potential adverse event, including barotrauma and prolonged ventilation.
This study will provide important data on the ventilation strategies used and its potential adverse events in unselected ICU patients with COVID-19 and thereby inform clinicians, patients, policy-makers, and future research in this area.
- Conditions
- ARDS Due to COVID-19
- Keywords
- ARDS, Mechanical Ventilation, COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI.
Low tidal volume ventilation (Vt 4-8 mL/kg of predicted body weight)
Measured: Until 90 days
Secondary outcomes (10)
Pneumothorax
Pneumothorax noted in the medical record
Measured: Until 90 days
Ventilator days
Number of days where the patients where the patient is ventilator depended
Measured: Until 90 days
Number of patients with prolonged ventilation
Patients with more than 30 ventilator days
Measured: Until 90 days
paO2/FiO2 ratio on days of ventilation
Ratio between measured arterial oxygen pressure and the fraction of inhaled oxygen
Measured: Until 90 days
The use of APRV
The use of Airway pressure release as primary ventilator setting
Measured: Until 90 days
Prone position
The use of prone position within the first 3 days and the use of prone position after day 3
Measured: Until 90 days
Time to spontaneous ventilation
Time measured in days until the patients no longer needs controlled ventilation
Measured: Until 90 days
Tracheostomy
Day after first intubation, Percutaneous dilatational tracheostomy (y/n), Surgical tracheostomy (y/n)
Measured: Until 90 days
Adjuvant drugs
Adjuvant drugs at any time during mechanical ventilation
Measured: Until 90 days
Mortality
Mortality at day 90
Measured: Until 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Jun 2021
- Primary completionFeb 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS Due to COVID-19Studies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Other
- Enrolment
- 1,193 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital, Bispebjerg Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Region Zealand
- Responsible party
- Principal investigator, Anne Craveiro Brøchner, University of Southern Denmark
- Investigators
- Anne C Brøchner, MD, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102630
- Sponsor's protocol ID
- 2020-C 19-29-10-21
- Status last verified
- Nov 2021
- First submitted
- 29 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mechanical Ventilation Strategies and Its Potential Adverse Events Among ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT05102630
- Acronym / sponsor ID
- 2020-C 19-29-10-21
- Conditions
- ARDS Due to COVID-19
- Keywords
- ARDS, Mechanical Ventilation, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,193 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital, Bispebjerg Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Region Zealand
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 1 Nov 2021 (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.
Mechanical ventilation is likely lifesaving in patients with coronavirus disease 2019 (COVID-19) but may also result in adverse events. Only few studies describe the strategies used and adverse effect of mechanical ventilation in an unselected population of ICU patients with COVID-19.
This study is designed to be a retrospective study focusing on all mechanical ventilated ICU patients with COVID-19 included in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e. a total of 1,193 patients. The investigators will register the use of the core interventions around mechanical ventilation and its potential adverse event, including barotrauma and prolonged ventilation.
This study will provide important data on the ventilation strategies used and its potential adverse events in unselected ICU patients with COVID-19 and thereby inform clinicians, patients, policy-makers, and future research in this area.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All mechanical ventilated patients registered in the national Danish COVID ICU database
Key inclusion criteria (4 listed)
- All mechanical ventilated patients registered in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e.
- Admitted to an ICU in Denmark
- Laboratory-confirmed SARS-CoV-2 infection
- Use of invasive mechanical ventilation (ventilation via a cuffed endotracheal tube) at any time during the ICU stay
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI.
Time frame: Until 90 days
Low tidal volume ventilation (Vt 4-8 mL/kg of predicted body weight)
10 secondary outcomes
Pneumothorax
Time frame: Until 90 days
Ventilator days
Time frame: Until 90 days
Number of patients with prolonged ventilation
Time frame: Until 90 days
paO2/FiO2 ratio on days of ventilation
Time frame: Until 90 days
The use of APRV
Time frame: Until 90 days
Prone position
Time frame: Until 90 days
Time to spontaneous ventilation
Time frame: Until 90 days
Tracheostomy
Time frame: Until 90 days
Adjuvant drugs
Time frame: Until 90 days
Mortality
Time frame: Until 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Nikolai arnold-larsen, MD contact
Anne C Brøchner, MD, PhD principal investigator
University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS Due to COVID-19, run by University of Southern Denmark at 2 sites in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne C Brøchner, MD, Ph D (+4529464468, anne.craveiro.broechner@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI. (time frame: Until 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2021.