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

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy Complication; Trachea
• Intervention / Treatment: Diagnostic test: Neck ultrasound

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Italy
  • Veneto
    • Padova, Veneto, Italy, 35127
      • University Hospital of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All adult patients accessing the operating room for any reason

Description

Inclusion Criteria:

• Patients of eighteen years or older
• Informed consent

Exclusion Criteria:

• Tracheostomized patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing surgical procedure; The following variables will be collected: age, weight, height, gender, previous neck surgery/radiotherapy, previous tracheostomy. Subsequently, through ultrasound examination, the vascular anatomy of the neck will be studied by dividing it into twelve anatomical quadrants: Four medial quadrants (thyroid membrane, cricoid membrane, and cricothyroid membrane; first tracheal ring, from the beginning of the second tracheal ring to the end of the third tracheal ring), laterally on both right and left sides of each quadrant, the lateral quadrants will be identified. An ultrasound examination with a linear probe with doppler technique will be performed for each quadrant to identify the vascular structures. For each quadrant, the presence of vessels, arterial or venous nature, and their diameter will be collected.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Tracheal Diseases
• Other Study ID Numbers: AOP3019/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No