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NCT Number: NCT06047665

Outcomes After Tracheal Cannula Removal

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).

Recruiting

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Key information

Conditions

Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabi Müller Verbiest, PhD

CONTACT

[email protected]

41 939 55 63 ext. 0041

Katharina Winiker, PhD

CONTACT

[email protected]

58 459 22 78 ext. 0041

Sponsors and collaborators

Lead sponsor

Katharina Winiker

Other

Collaborators

  • Swiss Paraplegic Research, Nottwil

Registry information

Official study title

Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study

Acronym: Dekan

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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