Outcomes After Tracheal Cannula Removal (Dekan)

April 25, 2026 updated by: Katharina Winiker

Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
for 3 months post-decannulation (assessment time points: 4 days, 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
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.
Questionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation 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
individual demographic and clinical patient characteristics
1 week pre-decannulation, (4 days for one select parameter), 1 month, and 3 months post-decannulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katharina Winiker

Collaborators

Swiss Paraplegic Research, Nottwil

Investigators

  • Principal Investigator: Katharina Winiker, PhD, Swiss University of Speech and Language Sciences
  • Study Chair: Gabi Müller Verbiest, PhD, Swiss Paraplegic Center Nottwil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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