Dekan: Outcomes After Tracheal Cannula Removal

Sponsor
Katharina Winiker (Other)
Overall Status
Recruiting
CT.gov ID
NCT06047665
Collaborator
Swiss Paraplegic Centre Nottwil (Other)
150
1
35.2
4.3

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

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study
    Actual Study Start Date :
    Aug 25, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2026
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. rate of physical complications post-decannulation [for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)]

    2. rate of reintubation post-decannulation [for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)]

    3. rate of recannulation post-decannulation [for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)]

    4. 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

    1. 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

    2. 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

    3. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    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:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Katharina Winiker, Principal Investigator, Swiss University of Speech and Language Sciences

    Study Results

    No Results Posted as of Sep 21, 2023