Ultrasound Guided Percutaneous Tracheostomy

Not Applicable

Completed

• Conditions: Tracheostomy Hemorrhage; Tracheostomy Complications; Other Tracheostomy Complications

• Registration Number: NCT01502657
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-04-21
• Primary Completion: 2011-11
• Status Verified: 2011-12
• Study Completion: 2011-12
• Study First Submitted QC: 2011-12-30
• Last Update Submitted: 2011-12-30
• Study First Posted: 2012-01-02
• Last Update Posted: 2012-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Procedure related complications	At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, Somme, France