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Outcomes After Tracheal Cannula Removal (Dekan)

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ClinicalTrials.gov Identifier: NCT06047665
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : April 19, 2024
Sponsor:
Collaborator:
Swiss Paraplegic Research, Nottwil
Information provided by (Responsible Party):
Katharina Winiker, Swiss University of Speech and Language Sciences

Study Description
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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
Tracheostomy

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
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study
Actual Study Start Date : August 25, 2023
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. rate of reintubation post-decannulation [ Time Frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) ]
  3. rate of recannulation post-decannulation [ Time Frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) ]
  4. rate of death post-decannulation [ Time Frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) ]

Secondary Outcome Measures :
  1. 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) ]
    including excessive secretion, altered respiratory frequency, respiratory insufficiency, respiratory infections, newly occuring neurological symptoms, sleep apnea, intratracheal complications, complications with tracheostoma

  2. 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 ]
    individual demographic and clinical patient characteristics

  3. 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 ]
    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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047665


Contacts
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Contact: Gabi Müller Verbiest, PhD 41 939 55 63 ext 0041 gabi.mueller@paraplegie.ch
Contact: Katharina Winiker, PhD 58 459 22 78 ext 0041 katharina.winiker@shlr.ch

Locations
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Switzerland
Swiss Paraplegic Center Nottwil Recruiting
Nottwil, Luzern, Switzerland, 6207
Contact: Gabi Müller, PhD    41 939 55 63 ext 0014    gabi.mueller@paraplegie.ch   
Contact: Sarah Stierli, BA    41 939 58 92 ext 0041    sarah.stierli@paraplegie.ch   
Sponsors and Collaborators
Katharina Winiker
Swiss Paraplegic Research, Nottwil
Investigators
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Principal Investigator: Katharina Winiker, PhD Swiss University of Speech and Language Sciences
Study Chair: Gabi Müller Verbiest, PhD Swiss Paraplegic Center Nottwil
More Information
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Responsible Party: Katharina Winiker, Principal Investigator, Swiss University of Speech and Language Sciences
ClinicalTrials.gov Identifier: NCT06047665    
Other Study ID Numbers: 2022-08
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katharina Winiker, Swiss University of Speech and Language Sciences:
Tracheostomy
Decannulation
Complications