Outcomes After Tracheal Cannula Removal

Recruiting

• Conditions: Tracheostomy

• Registration Number: NCT06047665
• Lead Sponsor: Katharina Winiker

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

Study Timeline

• Study Start: 2023-08-25
• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of reintubation 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)
rate of recannulation post-decannulation	for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)
rate of physical complications post-decannulation	for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation)

Secondary Outcome Measures

Name	Time	Method
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	individual demographic and clinical patient characteristics
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	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.
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)	including excessive secretion, altered respiratory frequency, respiratory insufficiency, respiratory infections, newly occuring neurological symptoms, sleep apnea, intratracheal complications, complications with tracheostoma

Trial Locations

Locations (1)

Swiss Paraplegic Center Nottwil; 🇨🇭 Nottwil, Luzern, Switzerland