TracheostomyDekanNCT06047665
Outcomes After Tracheal Cannula Removal
An observational study of Tracheostomy, run by Katharina Winiker at 1 site in Switzerland.
Trial summary
This longitudinal observational study involves an integrated knowledge translation (IKT) approach involving key stakeholders in the project team to evaluate the tracheostomy management in patients hospitalized in the Swiss Paraplegic Centre Nottwil (SPC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Aug 2023to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.
Who may be able to join
- at the time of recruitment, tracheotomized adult in-patients (≥ 18 years) of the SPC with any medical diagnosis
- decannulated in the Swiss Paraplegic Center Nottwil within the project's data collection period
- German, French, Italian or English as communication language
- study consent
Who cannot join
- patients for whom no decannulation is sought (e.g., due to degenerative illness)
- patients for whom decannulation is planned in a clinic other than the SPC (e.g., patients hospitalized in the SPC for weaning only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Center Nottwil
Nottwil, Canton of Lucerne, 6207
Gabi Müller, PhD, 41 939 55 63 ext. 0014, gabi.mueller@paraplegie.ch
Sarah Stierli, BA, 41 939 58 92 ext. 0041, sarah.stierli@paraplegie.ch
About this study
Official title: Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study
This longitudinal observational study involves an integrated knowledge translation (IKT) approach involving key stakeholders in the project team to evaluate the tracheostomy management in patients hospitalized in the Swiss Paraplegic Centre Nottwil (SPC).
Read the detailed description
Primary objective
- to evaluate the rate of physical complications (that require treatment, intubation, recannulation or lead to death) in patients hospitalized in the SPC over three months following the removal of the tracheal cannula (decannulation).
Secondary objectives
- to describe types of complications short-term (up to 4 days) and long-term (up to three months) post-decannulation
- to assess predictors for short- and long-term complications post-decannulation
- to explore patients' perspectives on decannulation outcomes
- to evaluate individual trajectories of the clinical decannulation protocol
- Conditions
- Tracheostomy
- Keywords
- Tracheostomy, Decannulation, Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of physical complications post-decannulation
Measured: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of reintubation post-decannulation
Measured: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of recannulation post-decannulation
Measured: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of death post-decannulation
Measured: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
Secondary outcomes (3)
types of decannulation-related physical complications short- and long-term
including excessive secretion, altered respiratory frequency, respiratory insufficiency, respiratory infections, newly occuring neurological symptoms, sleep apnea, intratracheal complications, complications with tracheostoma
Measured: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
candidate prognostic factors for physical complications post-decannulation
individual demographic and clinical patient characteristics
Measured: 1 week pre-decannulation, (4 days for one select parameter), 1 month, and 3 months post-decannulation
patients' perspectives on decannulation outcomes
A questionnaire will be used to assess advantages and disadvantages of the decannulation (8 questions, per question 3 - 6 pre-formulated answers to choose from). Additional, the Harvard Human Flourishing Measure (12 questions, rating from 0 to 10 per question, sum score to calculate the 'flourish measure') will be used.
Measured: Questionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation and 3 months post-decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start25 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
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 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katharina Winiker
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Responsible party
- Sponsor-investigator, Katharina Winiker, Swiss University of Speech and Language Sciences
- Investigators
- Katharina Winiker, PhD, Principal investigator, Swiss University of Speech and Language SciencesGabi Müller Verbiest, PhD, Study chair, Swiss Paraplegic Center Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047665
- Sponsor's protocol ID
- 2022-08
- Acronym
- Dekan
- Status last verified
- May 2025
- First submitted
- 30 Aug 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winiker K, Stierli S, Brinkhof MWG, Hamzic S, Schwegler H, Mueller G. Outcomes of Tracheostomy Decannulation: Study Protocol for a Longitudinal Observational Study. Int J Lang Commun Disord. 2026 Jan-Feb;61(1):e70165. doi: 10.1111/1460-6984.70165.
PubMed 41355759
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT06047665
- Acronym / sponsor ID
- Dekan / 2022-08
- Conditions
- Tracheostomy
- Keywords
- Tracheostomy, Decannulation, Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Katharina WinikerUniversity, hospital or other
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Sep 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.
This longitudinal observational study involves an integrated knowledge translation (IKT) approach involving key stakeholders in the project team to evaluate the tracheostomy management in patients hospitalized in the Swiss Paraplegic Centre Nottwil (SPC).
Detailed description
Primary objective
- to evaluate the rate of physical complications (that require treatment, intubation, recannulation or lead to death) in patients hospitalized in the SPC over three months following the removal of the tracheal cannula (decannulation).
Secondary objectives
- to describe types of complications short-term (up to 4 days) and long-term (up to three months) post-decannulation
- to assess predictors for short- and long-term complications post-decannulation
- to explore patients' perspectives on decannulation outcomes
- to evaluate individual trajectories of the clinical decannulation protocol
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.
Key inclusion criteria (4 listed)
- at the time of recruitment, tracheotomized adult in-patients (≥ 18 years) of the SPC with any medical diagnosis
- decannulated in the Swiss Paraplegic Center Nottwil within the project's data collection period
- German, French, Italian or English as communication language
- study consent
Key exclusion criteria (2 listed)
- patients for whom no decannulation is sought (e.g., due to degenerative illness)
- patients for whom decannulation is planned in a clinic other than the SPC (e.g., patients hospitalized in the SPC for weaning only)
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
rate of physical complications post-decannulation
Time frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of reintubation post-decannulation
Time frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of recannulation post-decannulation
Time frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of death post-decannulation
Time frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
3 secondary outcomes
types of decannulation-related physical complications short- and long-term
Time frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
candidate prognostic factors for physical complications post-decannulation
Time frame: 1 week pre-decannulation, (4 days for one select parameter), 1 month, and 3 months post-decannulation
patients' perspectives on decannulation outcomes
Time frame: Questionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation and 3 months post-decannulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 41355759Winiker K, Stierli S, Brinkhof MWG, Hamzic S, Schwegler H, Mueller G. Outcomes of Tracheostomy Decannulation: Study Protocol for a Longitudinal Observational Study. Int J Lang Commun Disord. 2026 Jan-Feb;61(1):e70165. doi: 10.1111/1460-6984.70165.
- Individual participant dataSharing planned: No
Related trials for Tracheostomy
Enrolling by invitation
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
Gastrostomy, Tracheostomy
Recruiting
Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
Endotracheal Aspiration, Tracheostomy Patients
Enrolling by invitationObservational study
A Voice Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
RecruitingObservational study
Increased Body Temperature Post Tracheostomy: a Retrospective Study
Tracheostomy Complication
Not yet recruitingObservational study
Trachphone vs Warm Air Humidification for Acute Trache Patients on ICU
Tracheostomy, Ventilated Patients
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.
Katharina Winiker, PhD principal investigator
Swiss University of Speech and Language Sciences
Gabi Müller Verbiest, PhD study chair
Swiss Paraplegic Center Nottwil
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 Katharina Winiker at 1 site in Switzerland.
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 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: looking for participants now, as of the sponsor's last update on 30 Apr 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabi Müller Verbiest, PhD (41 939 55 63 ext. 0041, gabi.mueller@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of physical complications post-decannulation (time frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)). The study lists 4 primary outcomes in all. 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 NCT06047665, 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 30 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.