Ultrasound Guided Percutaneous Tracheostomy

Tracheostomy Hemorrhage Clinical Trial

Official title:

Ultrasound Guided Percutaneous Tracheostomy in the ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502657
• Other study ID #: PI10-DR-GUINOT
• Secondary ID: 2010-A00901-38
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: December 30, 2011
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Other Tracheostomy Complications
• Postoperative Complications
• Tracheostomy Complications
• Tracheostomy Hemorrhage

Intervention

Device:
• Ultrasonography (EnVisor Philips Medical Systems)
Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;

Locations

Country	Name	City	State
France	CHU Amiens	Amiens	Somme

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Yes
Secondary	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.	The time will be calculated at the end of the procedure; an average of 30 minutes	No