Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| critical ill patients The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU |
Procedure: Percutaneous tracheostomy
Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.
|
Outcome Measures
Primary Outcome Measures
- Safety of percutaneous tracheostomy [at the beginning and at the end of the procedure]
Secondary Outcome Measures
- 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
- 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
- Evaluation of organ function [At 3, 6 , and 12 months after tracheostomy]
The investigator will perform a flexible fiberoptic laryngoscopy.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age >18
-
indication for tracheostomy
Exclusion Criteria:
- infectious disease of neck
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Genoa | Genoa | Italy | 16132 |
Sponsors and Collaborators
- University of Genova
Investigators
- Principal Investigator: Paolo Pelosi, University of Genoa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 53/12