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

• ClinicalTrials.gov Identifier: NCT06002178
• Recruitment Status: Completed
• First Posted: August 21, 2023
• Last Update Posted: November 18, 2023
• Sponsor: University of Padova
• Information provided by (Responsible Party): Alessandro De Cassai, University of Padova

Tracking Information

• First Submitted Date: August 15, 2023
• First Posted Date: August 21, 2023
• Last Update Posted Date: November 18, 2023
• Actual Study Start Date: August 14, 2023
• Actual Primary Completion Date: November 13, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2023)

• Mapping of artery and veins of the neck in the general population [ Time Frame: through study completion, an average of 1 year ]
  Described as the size of veins and arteries in the neck
• Size of artery and veins of the neck in the general population [ Time Frame: through study completion, an average of 1 year ]
  Described as the size of veins and arteries in the neck

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy
• Official Title: Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy

Brief 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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: All adult patients accessing the operating room for any reason

Condition

• Tracheostomy Complication
• Trachea

Intervention

Diagnostic Test: Neck ultrasound

A neck ultrasound will be performed in order to map superficial arteries and veins of the neck

Study Groups/Cohorts

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.

Intervention: Diagnostic Test: Neck ultrasound

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2023): 500
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 13, 2023
• Actual Primary Completion Date: November 13, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients of eighteen years or older
• Informed consent

Exclusion Criteria:

• Tracheostomized patients

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT06002178
• Other Study ID Numbers: AOP3019/2023
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Alessandro De Cassai, University of Padova
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Padova
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Padova
• Verification Date: November 2023