COVID-19NCT06346210
Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients
An observational study of COVID-19, run by Uppsala University at 1 site in Sweden.
Trial summary
Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Tracheostomy
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteSweden
- Study dates
- 2 Apr 2024to 2 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Invasively mechanically ventilated adults in the Swedish intensive care registry.
Who may be able to join
- Adult
- admitted to an intensive care unit in Sweden from 2020 to 2021
- Main discharge diagnosis COVID-19 (ICD-10, U07.1)
- Invasive mechanical ventilation
Who cannot join
- No Swedish personal identification number.
Trial locations and contacts
1 site in 1 country.
About this study
Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients.
Read the detailed description
The study hypothesis is that a strategy of tracheostomy during the second week of mechanical ventilation yields more IMV-free days and lower mortality than continued mechanical ventilation without tracheostomy, when efforts are made to neutralize immortal time bias.
The hypothesis has been slightly changed to accommodate the methods change described below.
Data sources Existing data provided for another project will be used.
Statistical methods:
A Markov multistate model with inverse probability weighting and landmark analyses at 7, 14, and 21 days from IMV start. The primary outcome is estimated ventilator-free days alive at day 60; secondary analyses includes 60-day mortality.
The methods has been changed to multistate + landmark because the data did not support a full cloning, censoring, weighing approach.
- Conditions
- COVID-19
- Being tested
- Tracheostomy
- Keywords
- Critical care, Tracheostomy, Mechanical ventilation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
Surgery for tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Not tracheostomised | Invasively mechanically ventilated COVID-19 patients who did not receive a tracheostomy within 60 days from tracheal intubation. | |
| Tracheostomised | Invasively mechanically ventilated COVID-19 patients who did receive a tracheostomy within 60 days from tracheal intubation. Receives: Procedure: Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days alive
Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation
Measured: 60 days.
Secondary outcomes (1)
60 day mortality
Mortality from any cause within 60 days from start of invasive mechanical intervention
Measured: 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start2 Apr 2024
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Healthcare Region Dalarna
- Responsible party
- Sponsor
- Investigators
- Björn Ahlström, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346210
- Sponsor's protocol ID
- UNT: U1111-1288-2037
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will be shared under the regulations of the European general data protection act and after researchers obtain relevant permissions from the Swedish ethical review authority.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients
- ClinicalTrials.gov ID
- NCT06346210
- Acronym / sponsor ID
- UNT: U1111-1288-2037
- Conditions
- COVID-19
- Keywords
- Critical care, Tracheostomy, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Healthcare Region Dalarna
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 3 Apr 2024 (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.
Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients.
Detailed description
The study hypothesis is that a strategy of tracheostomy during the second week of mechanical ventilation yields more IMV-free days and lower mortality than continued mechanical ventilation without tracheostomy, when efforts are made to neutralize immortal time bias.
The hypothesis has been slightly changed to accommodate the methods change described below.
Data sources Existing data provided for another project will be used.
Statistical methods:
A Markov multistate model with inverse probability weighting and landmark analyses at 7, 14, and 21 days from IMV start. The primary outcome is estimated ventilator-free days alive at day 60; secondary analyses includes 60-day mortality.
The methods has been changed to multistate + landmark because the data did not support a full cloning, censoring, weighing approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not tracheostomised | – | –Invasively mechanically ventilated COVID-19 patients who did not receive a tracheostomy within 60 days from tracheal intubation. |
| Tracheostomised | – | Procedure: TracheostomyInvasively mechanically ventilated COVID-19 patients who did receive a tracheostomy within 60 days from tracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasively mechanically ventilated adults in the Swedish intensive care registry.
Key inclusion criteria (4 listed)
- Adult
- admitted to an intensive care unit in Sweden from 2020 to 2021
- Main discharge diagnosis COVID-19 (ICD-10, U07.1)
- Invasive mechanical ventilation
Key exclusion criteria (1 listed)
- No Swedish personal identification number.
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 |
|---|---|---|
| TracheostomySurgery for tracheostomy | Procedure or surgery | Tracheostomised |
Primary outcome
Ventilator free days alive
Time frame: 60 days.
Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation
1 secondary outcome
60 day mortality
Time frame: 60 days.
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 6 May 2026.
- Individual participant dataSharing planned: No. Individual patient data will be shared under the regulations of the European general data protection act and after researchers obtain relevant permissions from the Swedish ethical review authority.
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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.
Björn Ahlström, PhD principal investigator
Uppsala University
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, run by Uppsala University 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 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: finished, as of the sponsor's last update on 6 May 2026. 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?
Ventilator free days alive (time frame: 60 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 6 May 2026.