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Ultrasound Guided Percutaneous Tracheostomy

Ultrasound Guided Percutaneous Tracheostomy in the ICU

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01502657
Enrollment
40
Registered
2012-01-02
Start date
2010-09-30
Completion date
2011-12-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Tracheostomy Complications, Tracheostomy Complications, Tracheostomy Hemorrhage

Keywords

percutaneous tracheostomy, ultrasonography, echography, critical care

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.

Interventions

DEVICEUltrasonography (EnVisor Philips Medical Systems)

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Procedure related complicationsAt the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeksComplications 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

MeasureTime frameDescription
Procedure timeThe time will be calculated at the end of the procedure; an average of 30 minutesThe total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026