Procedures and Follow-up of Percutaneous Tracheostomy in Intensive Care Unit

Study Overview
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Brief Summary
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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.

Official Title
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Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit

Conditions
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Acute Respiratory Failure, Neurological Disease, Heart Failure

Intervention / Treatment
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* Procedure: Percutaneous tracheostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 indication for tracheostomy Exclusion Criteria: infectious disease of neck

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| critical ill patients<br>The investigator will enroll all the critical ill patients undergoing percutaneous tracheostomy performed in ICU | Procedure: Percutaneous tracheostomy<br>* Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of percutaneous tracheostomy |  | at the beginning and at the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications | 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 | in the first 24 hours from the end of the procedure | 
| Late complications | Late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma. | from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks) | 
| Quality of life | The investigator will use the EURO-QOL | at 3, 6 and 12 months after tracheostomy | 
| Evaluation of organ function | The investigator will perform a flexible fiberoptic laryngoscopy. | At 3, 6 , and 12 months after tracheostomy | 
| Quality of voice | the investigator will use a KAY elemetrics analyzer. | At 3,6, 12 months after tracheostomy | 
| Mortality |  | at 3, 6 and 12 months from tracheostomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous tracheostomy, Intensive Care Unit, Ineffective Airway Clearance, Weaning failure