Health Trialsby

Outcomes After Tracheal Cannula Removal

ConditionTracheostomy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKatharina Winiker

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)

2

rate of reintubation post-decannulation

Time frame

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

3

rate of recannulation post-decannulation

Time frame

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

4

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 outcomes

1

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

Time frame

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

2

candidate prognostic factors for physical complications post-decannulation

individual demographic and clinical patient characteristics

Time frame

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

3

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.

Time frame

Questionnaire: 4 days, 1 month, and 3 months post-decannulation; Human Flourishing Measure: 1 week pre-decannulation and 3 months post-decannulation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Katharina Winiker

Lead sponsor

Swiss University of Speech and Language Sciences

Sponsor institution

Swiss Paraplegic Research, Nottwil

Collaborator

Source ClinicalTrials.gov