TracheostomyNCT05175859
Timing of Tracheostomy in COVID-19 - Impact on Mortality
An observational study of Tracheostomy, run by Goethe University at 1 site in Germany.
Trial summary
How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheostomy
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to 25 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with underlying sheer COVID-19 disease and need for endotracheal airway management. Who required a tracheostomy due to the prolonged ventilation and ventilatory weaning required.
Who may be able to join
- Severe COVID-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome.
Who cannot join
- COVID-19 disease, without the need for endotracheal ventilation.
- COVID-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Timing of Tracheostomy in COVID-19 Patients Changed and Its Impact on Mortality
How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS
- Conditions
- Tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early tracheostomy | Tracheostomy time before day 10 following endotracheal airway management and invasive ventilation. | |
| Late tracheostomy | Tracheostomy time after day 11 following endotracheal airway management and invasive ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Deaths in the course of treatment
Measured: During intensive care treatment (Usually within 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Apr 2020
- Primary completion1 Oct 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175859
- Sponsor's protocol ID
- Tracheostomy in COVID-19
- Status last verified
- Dec 2021
- First submitted
- 26 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Timing of Tracheostomy in COVID-19 Patients Changed and Its Impact on Mortality
- ClinicalTrials.gov ID
- NCT05175859
- Acronym / sponsor ID
- Tracheostomy in COVID-19
- Conditions
- Tracheostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 4 Jan 2022 (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.
How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early tracheostomy | – | –Tracheostomy time before day 10 following endotracheal airway management and invasive ventilation. |
| Late tracheostomy | – | –Tracheostomy time after day 11 following endotracheal airway management and invasive ventilation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with underlying sheer COVID-19 disease and need for endotracheal airway management. Who required a tracheostomy due to the prolonged ventilation and ventilatory weaning required.
Key inclusion criteria (1 listed)
- Severe COVID-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome.
Key exclusion criteria (2 listed)
- COVID-19 disease, without the need for endotracheal ventilation.
- COVID-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.
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
Mortality
Time frame: During intensive care treatment (Usually within 8 weeks)
Deaths in the course of treatment
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 4 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tracheostomy, run by Goethe University at 1 site in Germany.
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 1 inclusion and 2 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 4 Jan 2022. 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 Germany. 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?
Mortality (time frame: During intensive care treatment (Usually within 8 weeks)). 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 4 Jan 2022.