Outcomes After Tracheal Cannula Removal

Study Overview
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Brief Summary
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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
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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

Official Title
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Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study

Conditions
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Tracheostomy

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of physical complications post-decannulation |  | for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) | 
| rate of reintubation post-decannulation |  | for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) | 
| rate of recannulation post-decannulation |  | for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) | 
| rate of death post-decannulation |  | for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 week pre-decannulation, 4 days, 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. | Questionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation and 3 months post-decannulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Decannulation, Complications