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

Sponsor
University of Padova (Other)
Overall Status
Recruiting
CT.gov ID
NCT06002178
Collaborator
(none)
500
1
12
41.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Neck ultrasound

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy
Actual Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Aug 14, 2024
Anticipated Study Completion Date :
Aug 14, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Mapping of artery and veins of the neck in the general population [through study completion, an average of 1 year]

    Described as the size of veins and arteries in the neck

  2. Size of artery and veins of the neck in the general population [through study completion, an average of 1 year]

    Described as the size of veins and arteries in the neck

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients of eighteen years or older

  • Informed consent

Exclusion Criteria:
  • Tracheostomized patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Padova Padova Veneto Italy 35127

Sponsors and Collaborators

  • University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alessandro De Cassai, Principal Investigator, University of Padova
ClinicalTrials.gov Identifier:
NCT06002178
Other Study ID Numbers:
  • AOP3019/2023
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023