Airway Management, Heart Failure, Neurological Disease, Respiratory Failure
Conditions
Brief summary
Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.
Interventions
PROCEDURETracheostomy
Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.
Sponsors
University of Genova
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age \> 18 years * indications for tracheostomy
Exclusion criteria
* Infection/inflammation of neck tissue * Previous neck surgery causing abnormal anatomy of the site * Recent surgery of cervical spine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at ICU discharge | within 2 days after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | within 2 days after discharge, at 3, 6 and 12 months after tracheostomy | Quality of life will be evaluated at 3, 6 and 12 months after the discharge from the intensive care unit. |
| Laryngeal organ function | within 2 days after discharge, at 3, 6 and 12 months after tracheostomy | Laryngeal organ function will be evaluated at 3, 6 and 12 months after the discharge from intensive care unit. |
| Late complications | from day 2 until the discharge | — |
| Procedural findings of percutaneous tracheostomy | at the beginning and at the end of tracheostomy procedures | — |
| Early complication | in the first 24 hours from the end of the procedure | — |
Countries
Italy
Contacts
Primary ContactPaolo Pelosi, MD
Backup ContactMaria Vargas
Outcome results
None listed