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

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

Study Description
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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
Tracheostomy Complication Trachea Diagnostic Test: Neck ultrasound

Study Design
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Study Type : Observational
Actual 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 : August 14, 2023
Actual Primary Completion Date : November 13, 2023
Actual Study Completion Date : November 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All adult patients accessing the operating room for any reason
Criteria

Inclusion Criteria:

  • Patients of eighteen years or older
  • Informed consent

Exclusion Criteria:

  • Tracheostomized patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002178


Locations
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Italy
University Hospital of Padova
Padova, Veneto, Italy, 35127
Sponsors and Collaborators
University of Padova
More Information
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Responsible Party: Alessandro De Cassai, Principal Investigator, University of Padova
ClinicalTrials.gov Identifier: NCT06002178    
Other Study ID Numbers: AOP3019/2023
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tracheal Diseases
Respiratory Tract Diseases