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Completed

NCT Number: NCT01502657

Ultrasound Guided Percutaneous Tracheostomy

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

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Key information

Conditions

Tracheostomy Hemorrhage Other Tracheostomy Complications Tracheostomy Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, Somme, 80000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonography (EnVisor Philips Medical Systems)

Device

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

Other names: Echograph is EnVisor Philips, N°453561299512 rev A, CE0086

Primary outcomes

  1. 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

  1. Procedure time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Ultrasound Guided Percutaneous Tracheostomy in the ICU

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 2, 2012
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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