Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy

Tracheostomy Complication Clinical Trial

Official title:

Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06002178
• Other study ID #: AOP3019/2023
• Status: Completed
• Start date: August 14, 2023
• Est. completion date: November 13, 2023

Study information

• Verified date: November 2023
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tracheostomy is a commonly performed procedure in Intensive Care and its incidence tends to increase over time as a consequence of the increase in chronic diseases and the average age of the population accessing Intensive Care.

Surgical open tracheostomy (ST) is the standard procedure but has a relatively high incidence of peristomal infections and perioperative bleeding. Percutaneous dilatational tracheostomy (PDT) was introduced in 1985 and has since become a common bedside procedure. Compared to open ST, PDT has the advantages of a lower risk of wound infection, lower bleeding-related mortality, shorter procedure times, and improved cost-effectiveness.

Fiberoptic bronchoscopy is commonly used during PDT to verify the safety of direct tracheal access [5]. However, bronchoscopy-guided PDT has several limitations regarding the precise identification of cervical anatomical structures and the prevention of complications such as vascular injury.

Preliminary ultrasound examination of neck anatomy has numerous potential benefits, including increased safety during the procedure, identification of cervical vascularization, and localization of the tracheal puncture site with lower risk of complications [6-8]. Several studies have shown that the use of ultrasound in a preliminary and real-time manner can improve first-pass success rate and puncture accuracy, reduce procedure time, and complications.

The objective of this study is to map the arterial and venous vascular anatomy of the neck in order to identify points with a lower risk of vascular injury during PDT. This helps prevent bleeding during tracheostomy, which is one of the major complications associated with the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of eighteen years or older

• Informed consent

Exclusion Criteria:

• Tracheostomized patients

Related Conditions & MeSH terms

• Trachea
• Tracheal Diseases
• Tracheostomy Complication

Intervention

Diagnostic Test:
• Neck ultrasound
A neck ultrasound will be performed in order to map superficial arteries and veins of the neck

Locations

Country	Name	City	State
Italy	University Hospital of Padova	Padova	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mapping of artery and veins of the neck in the general population	Described as the size of veins and arteries in the neck	through study completion, an average of 1 year
Primary	Size of artery and veins of the neck in the general population	Described as the size of veins and arteries in the neck	through study completion, an average of 1 year