Ultrasound Guided Percutaneous Tracheostomy

NCT ID: NCT01502657

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Tracheostomy Hemorrhage; Tracheostomy Complications; Other Tracheostomy Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Ultrasonography (EnVisor Philips Medical Systems)

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

Intervention Type: DEVICE

Other Intervention Names

Echograph is EnVisor Philips; N°453561299512 rev A; CE0086

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre grégoire Guinot, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire, Amiens

Locations

CHU Amiens

Amiens, Somme, France

Countries

France

References

Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.

Reference Type: RESULT

PMID: 22390815 (View on PubMed)

Other Identifiers

2010-A00901-38

Identifier Type: OTHER

Identifier Source: secondary_id

PI10-DR-GUINOT

Identifier Type: -

Identifier Source: org_study_id