Outcomes After Tracheal Cannula Removal (Dekan)

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ClinicalTrials.gov Identifier: NCT06047665

Recruitment Status : Recruiting

First Posted : September 21, 2023

Last Update Posted : April 19, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Swiss Paraplegic Research, Nottwil

Information provided by (Responsible Party):

Katharina Winiker, Swiss University of Speech and Language Sciences

Tracking Information

First Submitted Date

August 30, 2023

First Posted Date

September 21, 2023

Last Update Posted Date

April 19, 2024

Actual Study Start Date

August 25, 2023

Estimated Primary Completion Date

August 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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) ]
rate of reintubation post-decannulation [ Time Frame: 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) ]
rate of death post-decannulation [ Time Frame: for 3 months post-decannulation (assessment time points: 4 days, 1 month, and 3 months post-decannulation) ]

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

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
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
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.

Original Secondary Outcome Measures

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
candidate prognostic factors for physical complications post-decannulation [ Time Frame: 1 week pre-decannulation, 4 days, 1 month, and 3 months post-decannulation ]
individual demographic and clinical patient characteristics
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.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Outcomes After Tracheal Cannula Removal

Official Title

Tracheostomy Decannulation Outcomes: A Longitudinal Observational Study

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 Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Tracheotomized patients hospitalized in the Swiss Paraplegic Centre Nottwil.

Condition

Tracheostomy

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

150

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

August 2026

Estimated Primary Completion Date

August 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact: Gabi Müller Verbiest, PhD	41 939 55 63 ext 0041	gabi.mueller@paraplegie.ch
Contact: Katharina Winiker, PhD	58 459 22 78 ext 0041	katharina.winiker@shlr.ch

Listed Location Countries

Switzerland

Removed Location Countries

Administrative Information

NCT Number

NCT06047665

Other Study ID Numbers

2022-08

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Current Responsible Party

Katharina Winiker, Swiss University of Speech and Language Sciences

Original Responsible Party

Same as current

Current Study Sponsor

Katharina Winiker

Original Study Sponsor

Same as current

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

PRS Account

Swiss University of Speech and Language Sciences

Verification Date

April 2024

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