Quality of Life, Tracheostomy Complication
Conditions
Brief summary
Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy. Participant Population/Primary Condition: Patients admitted to Intensive Care Main Questions Aims to Answer: 1. \- What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy? 2. \- How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life? Participants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons. At the two-year follow-up, the health-related quality of life will be assessed
Interventions
PROCEDUREPercutaneous tracheostomy
Percutaneous tracheostomy is a widely used technique in intensive care. It involves creating a passage between the tracheal lumen and the outside, through which a cannula is placed.
Sponsors
Azienda Usl di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years * Presence of indication for tracheostomy
Exclusion criteria
* Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck phlegmon | 7 days | Neck phlegmon in the incisional site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Stay | 1 year | Days of ICU stay |
| Hospital Stay | 1 year | Days of hospital stay |
| Mortality | 30 days | 30 days mortality |
| Dysphonia | 2 years | Voice Handicap Index - VHI-10 questionnaire |
| Dysphagia | 2 years | Eating Attitude test - EAT-10 questionnaire |
| Dyspnoea | 2 years | Modified Medical Research Council Dyspnea Scale - mMRC-10 |
| Cough | 2 years | Leicester Cough Questionnaire - LCQ |
| Health related quality of life | 2 years | 15D instrument |
Countries
Italy
Contacts
Primary ContactLorenzo Gamberini, MD
Outcome results
None listed