Outcomes After Tracheal Cannula Removal

NCT06047665 | Recruiting

• 1 other identifier: 2022-08
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Tracheostomy

Keywords

Tracheostomy; Decannulation; Complications

Outcome Measures

Primary Outcomes (4)

• rate of physical complications post-decannulation

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

• rate of reintubation post-decannulation

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

• rate of recannulation post-decannulation

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

• rate of death post-decannulation

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

Secondary Outcomes (3)

• 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)

• candidate prognostic factors for physical complications post-decannulation

  1 week pre-decannulation, (4 days for one select parameter), 1 month, and 3 months post-decannulation

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Katharina Winiker: lead
• Swiss Paraplegic Research, Nottwil: collaborator

Study Sites (1)

Swiss Paraplegic Center Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Katharina Winiker, PhD

  Swiss University of Speech and Language Sciences

  PRINCIPAL INVESTIGATOR

• Gabi Müller Verbiest, PhD

  Swiss Paraplegic Center Nottwil

  STUDY CHAIR

Central Study Contacts

Gabi Müller Verbiest, PhD

CONTACT

41 939 55 63; gabi.mueller@paraplegie.ch

Katharina Winiker, PhD

CONTACT

58 459 22 78; katharina.winiker@shlr.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 21, 2023
• Study Start: August 25, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)