Clinical trial NCT06047665: Outcomes After Tracheal Cannula Removal
Official title: Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheostomy
Keywords: Tracheostomy
Decannulation
Complications
Lead sponsor: Swiss University of Speech and Language Sciences
Sponsor class: OTHER
Collaborators: name: Swiss Paraplegic Research, Nottwil
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.

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).

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

Eligibility 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)

Primary outcomes:
measure: rate of physical complications post-decannulation
timeFrame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
measure: rate of reintubation post-decannulation
timeFrame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
measure: rate of recannulation post-decannulation
timeFrame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
measure: rate of death post-decannulation
timeFrame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
Secondary outcomes:
measure: types of decannulation-related physical complications short- and long-term
timeFrame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
measure: candidate prognostic factors for physical complications post-decannulation
timeFrame: 1 week pre-decannulation, (4 days for one select parameter), 1 month, and 3 months post-decannulation
measure: patients' perspectives on decannulation outcomes
timeFrame: Questionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation and 3 months post-decannulation
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Center Nottwil
state: Luzern
Study officials:
affiliation: Swiss University of Speech and Language Sciences
name: Katharina Winiker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Paraplegic Center Nottwil
name: Gabi Müller Verbiest, PhD
role: STUDY_CHAIR
References: