Ultrasound Guided Percutaneous Tracheostomy

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.

Detailed Description
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Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.

Official Title
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Ultrasound Guided Percutaneous Tracheostomy in the ICU

Conditions
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Tracheostomy Hemorrhage, Tracheostomy Complications, Other Tracheostomy Complications

Intervention / Treatment
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* Device: Ultrasonography (EnVisor Philips Medical Systems)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients hospitalized in ICU in whom percutaneous tracheostomy is indicated, patients aged > 18 years old, Exclusion Criteria: age less than 18 years, clotting disorder, infection at the puncture site, emergency tracheostomy

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasonography (EnVisor Philips Medical Systems)|Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure related complications | Complications are: 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 3), surgical conversion and percutaneous tracheostomy failure, bleeding (compressible, incompressible, requiring administration of labile blood products), pneumothorax, pneumomediastinum, tracheostomy puncture site infection, surgical conversion, subglottic stenosis, fracture of a tracheal cartilage, granuloma. | At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | The total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy. | The time will be calculated at the end of the procedure; an average of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous tracheostomy, ultrasonography, echography, critical care