Outcomes After Tracheal Cannula Removal

Tracheostomy Clinical Trial

— Dekan  

Official title:

Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047665
• Other study ID #: 2022-08
• Status: Recruiting
• Start date: August 25, 2023
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Swiss University of Speech and Language Sciences
• Contact: Gabi Müller Verbiest, PhD
• Phone: 41 939 55 63
• Email: gabi.mueller[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tracheostomy

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Center Nottwil	Nottwil	Luzern

Sponsors (2)

Lead Sponsor	Collaborator
Katharina Winiker	Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of physical complications post-decannulation		for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
Primary	rate of reintubation post-decannulation		for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
Primary	rate of recannulation post-decannulation		for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
Primary	rate of death post-decannulation		for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
Secondary	types of decannulation-related physical complications short- and long-term	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)
Secondary	candidate prognostic factors for physical complications 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
Secondary	patients' perspectives on decannulation outcomes	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