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Clinical Trials/NCT01502657
NCT01502657
Completed
Not Applicable

Ultrasound Guided Percutaneous Tracheostomy in the ICU

Centre Hospitalier Universitaire, Amiens1 site in 1 country40 target enrollmentSeptember 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tracheostomy Hemorrhage
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
40
Locations
1
Primary Endpoint
Procedure related complications
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2010
End Date
December 1, 2011
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Procedure related complications

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

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 Outcomes

  • Procedure time(The time will be calculated at the end of the procedure; an average of 30 minutes)

Study Sites (1)

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