Tracheostomy Clinical Trial
— TRACHOfficial title:
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
NCT number | NCT04647968 |
Other study ID # | 2021-3699 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 12, 2021 |
Est. completion date | March 2024 |
The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | March 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Being covered by the RAMQ - Having a tracheostomy either percutaneous or surgical - Being ready for canula removal and closure of the fistula Exclusion Criteria: - Presenting a contraindication to primary tracheotomy closure (granuloma) - Unable to consent - Refusal to participate |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction in regards to the scar (change) | This outcome will evaluate patient satisfaction in regards to his tracheotomy scar following closure, measured with the Patient observer scar assesment scale (POSAS) validated questionnaire. A high score means a worse outcome. | 1 week, 1 month, 3 months, 6 months | |
Secondary | Healing time | This outcome will evaluate time until full closure of the wound using both methods of closure. | 6 months | |
Secondary | Respiratory complications | The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure. | 6 months | |
Secondary | Self reported quality of life related to dysphonia (change) | The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. The investigators are going to use the Voice Handicap Index (VHI-10) validated questionnaire to better assess this outcome. A high score means a worse outcome, the highest score being 40. | 1 week, 1 month, 3 months, 6 months | |
Secondary | Persisting fistula | This outcome intends to evaluate the frequency of persisting fistula using either method of closure. | 6 months | |
Secondary | Self reported quality of life related to dysphagia (change) | The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. We are going to use the EAT-10 validated questionnaire to better assess this outcome. A high score means a worse outcome, the highest score being 40. | 1 week, 1 month, 3 months, 6 months | |
Secondary | Self reported quality of life related to dyspnea (change) | The goal of this outcome is to evaluate the self reported quality of life of patients following tracheotomy closed by either mean. This will be measure by the Dyspnea Index (DI) validated questionnaire but also with the follow-up history. The Dyspnea Index questionnaire has a maximum score of 40. A high score means a worse outcome. | 1 week, 1 month, 3 months, 6 months |
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