Post Tracheostomy Complications, Tracheostomy, Tracheostomy Complication
Conditions
Keywords
tracheostomy, tracheostomy closure, tracheocutaneous fistula
Brief summary
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.
Detailed description
In this study the investigators wish to recruit patients with a tracheotomy that has been installed for various reasons and that is ready for closure. The investigators intend to randomly allocate them a mean of closure, either primary or secondary. Once the fistula is closed, the investigators will follow them over a substantial period of time to compare outcomes of each mean of closing. Different questionnaires will be used to best evaluate a range of variables.
Interventions
PROCEDUREPrimary closure of tracheo-cutaneous fistula
This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.
PROCEDURESecondary closure of tracheo-cutaneous fistula
This procedure will follow protocoled steps. It consists of removing the tracheotomy canula and applying ointment and an Elastoplast on the site, which will be changed regularly until full healing of the wound.
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking because it is a surgical procedure
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction in regards to the scar (change) | 1 week, 1 month, 3 months, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory complications | 6 months | The investigators wish to establish whether there is a difference in respiratory complications occurence between the two means of closure. |
| Self reported quality of life related to dysphonia (change) | 1 week, 1 month, 3 months, 6 months | 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. |
| Healing time | 6 months | This outcome will evaluate time until full closure of the wound using both methods of closure. |
| Self reported quality of life related to dysphagia (change) | 1 week, 1 month, 3 months, 6 months | 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. |
| Self reported quality of life related to dyspnea (change) | 1 week, 1 month, 3 months, 6 months | 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. |
| Persisting fistula | 6 months | This outcome intends to evaluate the frequency of persisting fistula using either method of closure. |
Countries
Canada
Contacts
Primary ContactSimon Brisebois, MD, MSC
Backup ContactBrigitte Routhier-Chevrier, MD
Outcome results
None listed