Investigating risk factors for neck phlegmon after tracheostomy in ICU patients
Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU
Azienda Usl di Bologna · NCT06552676
This study looks at the risk factors for developing neck infections after a tracheostomy in ICU patients to see how it affects their recovery and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Usl di Bologna (other gov) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06552676 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the incidence and risk factors associated with the development of tracheal phlegmon in patients who undergo percutaneous tracheostomy in an intensive care unit. Participants will be monitored for 7 days post-procedure to identify any occurrences of phlegmon, and their health-related quality of life will be assessed at a two-year follow-up. The study seeks to understand how the appearance of tracheal phlegmon affects the duration of intensive care stay, overall hospital stay, mortality rates, and quality of life outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who require a tracheostomy.
Not a fit: Patients who experience failure of the percutaneous tracheostomy technique or require surgical tracheostomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients undergoing tracheostomy, potentially reducing complications and enhancing quality of life.
How similar studies have performed: While there may be studies on tracheostomy complications, this specific investigation into neck phlegmon risk factors appears to be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna
- Maggiore Hospital Carlo Alberto Pizzardi — Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Lorenzo Gamberini, MD
- Email: gamberini6@ausl.bologna.it
- Phone: +393403550540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tracheostomy Complication, Quality of Life