Acute Respiratory Failure, Heart Failure, Neurological Disease
Conditions
Keywords
Percutaneous tracheostomy, Intensive Care Unit, Ineffective Airway Clearance, Weaning failure
Brief summary
Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.
Interventions
PROCEDUREPercutaneous tracheostomy
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.
Sponsors
University of Genova
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* age \>18 * indication for tracheostomy
Exclusion criteria
* infectious disease of neck
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of percutaneous tracheostomy | at the beginning and at the end of the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late complications | from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks) | Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma. |
| Quality of life | at 3, 6 and 12 months after tracheostomy | The investigator will use the EURO-QOL |
| Early complications | in the first 24 hours from the end of the procedure | Early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax |
| Quality of voice | At 3,6, 12 months after tracheostomy | the investigator will use a KAY elemetrics analyzer. |
| Mortality | at 3, 6 and 12 months from tracheostomy | — |
| Evaluation of organ function | At 3, 6 , and 12 months after tracheostomy | The investigator will perform a flexible fiberoptic laryngoscopy. |
Countries
Italy
Contacts
Primary ContactPaolo Pelosi, professor
Outcome results
None listed