ARDS, HumanNCT05693051
Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
An observational study of ARDS, Human and Extracorporeal Membrane Oxygenation, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- ARDS, Human, Extracorporeal Membrane Oxygenation, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Prone position ventilation
- How many people
- 68 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2020to 1 Nov 2022
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a nationwide retrospective cohort study of a cohort of 68 patients with PCR confirmed SARS-Cov-2 ARDS, treated with V-V ECMO in the two VV-ECMO centers in Denmark: Aarhus University Hospital in west Denmark and University Hospital Rigshospitalet in Copenhagen, East Denmark. Patients were admitted in the period from 17. March 2020 to 31. December 2021.
Who may be able to join
None listed.
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital, CardioThoracic Intensive care Unit
Aarhus, 8200
University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care
Copenhagen, 2100
About this study
Official title: Use of Prone Position Ventilation (PPV) in Danish Patients With COVID-19 Induced Severe Adult Respiratory Distress Syndrome (ARDS) Treated With Veno-Venous Extracorporeal Membrane Oxygenation (VV-ECMO)
Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high
Read the detailed description
Purpose: To describe the use and effects of prone position ventilation (PPV) in patients with COVID-19 induced Adult Respiratory Distress Syndrome (ARDS), treated with Veno-Venous Extracorporeal membrane oxygenation (VV-ECMO).
Methods: Nationwide retrospective analysis of all COVID-19 patients in Denmark from March 2020 - December 2021with severe ARDS and need of VV-ECMO treatment. Data on the number of patients treated with PPV, number of PPV-events, timing, the time spent in prone position, physiological response types, adverse events and outcomes are reported.
- Conditions
- ARDS, Human, Extracorporeal Membrane Oxygenation, COVID-19 Acute Respiratory Distress Syndrome, Prone Position, Adverse Event
- Being tested
- Prone position ventilation
- Keywords
- ARDS, VV-ECMO, Prone position ventilation, Adverse Events
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position ventilationOther
Turning the patient prone for 16 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day mortality
all cause mortality 90 days after ECMO start
Measured: 90 days
Secondary outcomes (3)
Time-to-wean
Time from ECMO start to succesful weaning from ECMO
Measured: From start of ECMO treatment to succesful weaning from ECMO
Recruitment Response to prone position ventilation
lung recruitment
Measured: from prone position start to prone position end
Oxygenation Response to prone position ventilation
Oxygenation
Measured: from prone position start to prone position end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Oct 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Vibeke Lind Jørgensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Vibeke L Jorgensen, M.D, Principal investigator, Department of CardioThoracic Anesthesia and Intensive Care, Rigshospitalet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693051
- Sponsor's protocol ID
- 20049299-PPV
- Status last verified
- Mar 2023
- First submitted
- 18 Jan 2023
- Last updated
- 29 Mar 2023
- 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Prone Position Ventilation (PPV) in Danish Patients With COVID-19 Induced Severe Adult Respiratory Distress Syndrome (ARDS) Treated With Veno-Venous Extracorporeal Membrane Oxygenation (VV-ECMO)
- ClinicalTrials.gov ID
- NCT05693051
- Acronym / sponsor ID
- 20049299-PPV
- Conditions
- ARDS, Human, Extracorporeal Membrane Oxygenation, COVID-19 Acute Respiratory Distress Syndrome, Prone Position, Adverse Event
- Keywords
- ARDS, VV-ECMO, Prone position ventilation, Adverse Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 20 Jan 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.
Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high
Detailed description
Purpose: To describe the use and effects of prone position ventilation (PPV) in patients with COVID-19 induced Adult Respiratory Distress Syndrome (ARDS), treated with Veno-Venous Extracorporeal membrane oxygenation (VV-ECMO).
Methods: Nationwide retrospective analysis of all COVID-19 patients in Denmark from March 2020 - December 2021with severe ARDS and need of VV-ECMO treatment. Data on the number of patients treated with PPV, number of PPV-events, timing, the time spent in prone position, physiological response types, adverse events and outcomes are reported.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a nationwide retrospective cohort study of a cohort of 68 patients with PCR confirmed SARS-Cov-2 ARDS, treated with V-V ECMO in the two VV-ECMO centers in Denmark: Aarhus University Hospital in west Denmark and University Hospital Rigshospitalet in Copenhagen, East Denmark. Patients were admitted in the period from 17. March 2020 to 31. December 2021.
Key inclusion criteria (0 listed)
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone position ventilationTurning the patient prone for 16 hours | Other | – |
Primary outcome
90 day mortality
Time frame: 90 days
all cause mortality 90 days after ECMO start
3 secondary outcomes
Time-to-wean
Time frame: From start of ECMO treatment to succesful weaning from ECMO
Recruitment Response to prone position ventilation
Time frame: from prone position start to prone position end
Oxygenation Response to prone position ventilation
Time frame: from prone position start to prone position end
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 29 Mar 2023.
- 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.
Vibeke L Jorgensen, M.D principal investigator
Department of CardioThoracic Anesthesia and Intensive Care, Rigshospitalet University Hospital
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, Human and Extracorporeal Membrane Oxygenation, run by Copenhagen University Hospital, Rigshospitalet 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 0 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 29 Mar 2023. 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?
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?
90 day mortality (time frame: 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 29 Mar 2023.