Covid-19TTCOV19NCT04412356
Timing of Tracheotomy in Covid-19 Patients
A study testing Tracheotomy in people with Covid-19 and ARDS, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, ARDS, Tracheostomy Complication
- What is being tested?
- Tracheotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 6 Jun 2020to 20 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Verified Covid-19 infection
- Intubated due to respiratory insufficiency and need for mechanical ventilation
- Informed consent from patient or relative
Who cannot join
- Age below 18 years
- Need for mechanical ventilation less than 14 days
- Tracheotomy not possible within 7 days
- Tracheotomy not possible due to anatomical or other medical reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.
- Conditions
- Covid-19, ARDS, Tracheostomy Complication, Respiratory Insufficiency, Corona Virus Infection
- Being tested
- Tracheotomy
- Keywords
- Covid-19, Tracheotomy, Tracheostomy, RCT, ARDS
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheotomyProcedure or surgery
Surgical procedure to secure airway
| Study group | Role | What they receive |
|---|---|---|
| Early tracheotomy | Experimental | Tracheotomy within 7 days after intubation. Receives: Procedure: Tracheotomy |
| Late tracheotomy | Active comparator | Tracheotomy after at least 10 days after intubation. Receives: Procedure: Tracheotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation
Number of days with mechanical ventilation
Measured: Through the individual ICU stay assessed up to 60 days
Secondary outcomes (5)
ICU stay
Number of days at ICU
Measured: Through the individual ICU stay assessed up to 60 days
Oxygen support
Number of days with need of additional oxygen support
Measured: Through the individual ICU stay assessed up to 60 days
Sedation
Number of days with the need of sedation
Measured: Through the individual ICU stay assessed up to 60 days
Adverse events
Various adverse events associated with the tracheotomy/tracheostomy
Measured: Through the individual ICU stay assessed up to 60 days
Mortality
Mortality
Measured: Through the individual ICU stay assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start6 Jun 2020
- Primary completion1 Jun 2021
- Study completion20 Sep 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 Sahlgrenska University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single blinded, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Bergquist, Sahlgrenska University Hospital
- Investigators
- Henrik Bergquist, Assoc Prof, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412356
- Sponsor's protocol ID
- HBergquist
- Acronym
- TTCOV19
- Status last verified
- Sep 2021
- First submitted
- 24 May 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eeg-Olofsson M, Pauli N, Hafsten L, Jacobsson J, Lundborg C, Brink M, Larsson H, Lindell E, Lowhagen K, Gisslen M, Bergquist H. TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial. Crit Care. 2022 May 18;26(1):142. doi: 10.1186/s13054-022-04005-0.
PubMed 35585614
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04412356
- Acronym / sponsor ID
- TTCOV19 / HBergquist
- Conditions
- Covid-19, ARDS, Tracheostomy Complication, Respiratory Insufficiency, Corona Virus Infection
- Keywords
- Covid-19, Tracheotomy, Tracheostomy, RCT, ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 2 Jun 2020 (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.
Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single blinded, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Early tracheotomy | Experimental | Procedure: TracheotomyTracheotomy within 7 days after intubation. |
| Late tracheotomy | Active comparator | Procedure: TracheotomyTracheotomy after at least 10 days after intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Verified Covid-19 infection
- Intubated due to respiratory insufficiency and need for mechanical ventilation
- Informed consent from patient or relative
Key exclusion criteria (4 listed)
- Age below 18 years
- Need for mechanical ventilation less than 14 days
- Tracheotomy not possible within 7 days
- Tracheotomy not possible due to anatomical or other medical reasons
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 |
|---|---|---|
| TracheotomySurgical procedure to secure airway | Procedure or surgery | Early tracheotomy, Late tracheotomy |
Primary outcome
Mechanical ventilation
Time frame: Through the individual ICU stay assessed up to 60 days
Number of days with mechanical ventilation
5 secondary outcomes
ICU stay
Time frame: Through the individual ICU stay assessed up to 60 days
Oxygen support
Time frame: Through the individual ICU stay assessed up to 60 days
Sedation
Time frame: Through the individual ICU stay assessed up to 60 days
Adverse events
Time frame: Through the individual ICU stay assessed up to 60 days
Mortality
Time frame: Through the individual ICU stay assessed up to 90 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 22 Sep 2021.
- Derived from this study: PubMed 35585614Eeg-Olofsson M, Pauli N, Hafsten L, Jacobsson J, Lundborg C, Brink M, Larsson H, Lindell E, Lowhagen K, Gisslen M, Bergquist H. TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial. Crit Care. 2022 May 18;26(1):142. doi: 10.1186/s13054-022-04005-0.
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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.
Henrik Bergquist, Assoc Prof principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheotomy in people with Covid-19 and ARDS, run by Sahlgrenska University Hospital 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 3 inclusion and 4 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 22 Sep 2021. 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?
Mechanical ventilation (time frame: Through the individual ICU stay assessed up to 60 days). 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 NCT04412356, 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 22 Sep 2021.