Menu
Recruiting NCT06047665

Outcomes After Tracheal Cannula Removal

Observational Tracheostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tracheostomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study

Overview

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

Primary outcome measures

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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Swiss Paraplegic Center Nottwil — Nottwil

Publications

  • Winiker K, Stierli S, Brinkhof MWG, Hamzic S, Schwegler H, Mueller G. Outcomes of Tracheostomy Decannulation: Study Protocol for a Longitudinal Observational Study. Int J Lang Commun Disord. 2026 Jan-Feb;61(1):e70165. doi: 10.1111/1460-6984.70165. PMID 41355759

Identifiers

NCT: NCT06047665 · 2022-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗