Ultrasound Guided Percutaneous Tracheostomy

Centre Hospitalier Universitaire, Amiens40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Tracheostomy Hemorrhage Tracheostomy Complications Other Tracheostomy Complications

Interventions

Ultrasonography (EnVisor Philips Medical Systems)DEVICE

Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Amiens

Amiens, Somme, France

Outcomes

Primary Outcomes

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.

Time frame: At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcomes

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.

Time frame: The time will be calculated at the end of the procedure; an average of 30 minutes

Data from ClinicalTrials.gov

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