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Outcomes After Tracheal Cannula Removal

Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06047665
Acronym
Dekan
Enrollment
150
Registered
2023-09-21
Start date
2023-08-25
Completion date
2026-08-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomy

Keywords

Tracheostomy, Decannulation, Complications

Brief 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).

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

Interventions

None listed

Sponsors

Katharina Winiker
Lead SponsorOTHER
Swiss Paraplegic Research, Nottwil
CollaboratorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
rate of physical complications post-decannulationfor 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of reintubation post-decannulationfor 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of recannulation post-decannulationfor 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of death post-decannulationfor 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)

Secondary

MeasureTime frameDescription
types of decannulation-related physical complications short- and long-termfor 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)including excessive secretion, altered respiratory frequency, respiratory insufficiency, respiratory infections, newly occuring neurological symptoms, sleep apnea, intratracheal complications, complications with tracheostoma
candidate prognostic factors for physical complications post-decannulation1 week pre-decannulation, (4 days for one select parameter), 1 month, and 3 months post-decannulationindividual demographic and clinical patient characteristics
patients' perspectives on decannulation outcomesQuestionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation and 3 months post-decannulationA 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.

Countries

Switzerland

Contacts

CONTACTGabi Müller Verbiest, PhD
gabi.mueller@paraplegie.ch41 939 55 63
CONTACTKatharina Winiker, PhD
katharina.winiker@shlr.ch58 459 22 78
PRINCIPAL_INVESTIGATORKatharina Winiker, PhD

Swiss University of Speech and Language Sciences

STUDY_CHAIRGabi Müller Verbiest, PhD

Swiss Paraplegic Center Nottwil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026