Dekan: Outcomes After Tracheal Cannula Removal
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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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
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to describe types of complications short-term (up to 4 days) and long-term (up to three months) post-decannulation
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to assess predictors for short- and long-term complications post-decannulation
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to explore patients' perspectives on decannulation outcomes
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to evaluate individual trajectories of the clinical decannulation protocol
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- types of decannulation-related physical complications short- and long-term [for 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-decannulation [1 week pre-decannulation, 4 days, 1 month, and 3 months post-decannulation]
individual demographic and clinical patient characteristics
- patients' perspectives on decannulation outcomes [Questionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation and 3 months post-decannulation]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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at the time of recruitment, tracheotomized adult in-patients (≥ 18 years) of the SPC with any medical diagnosis
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decannulated in the Swiss Paraplegic Center Nottwil within the project's data collection period
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German, French, Italian or English as communication language
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study consent
Exclusion Criteria:
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patients for whom no decannulation is sought (e.g., due to degenerative illness)
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patients for whom decannulation is planned in a clinic other than the SPC (e.g., patients hospitalized in the SPC for weaning only)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Swiss Paraplegic Center Nottwil | Nottwil | Luzern | Switzerland | 6207 |
Sponsors and Collaborators
- Katharina Winiker
- Swiss Paraplegic Centre Nottwil
Investigators
- Principal Investigator: Katharina Winiker, PhD, Swiss University of Speech and Language Sciences
- Study Chair: Gabi Müller Verbiest, PhD, Swiss Paraplegic Center Nottwil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-08