NCT06002178

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

Completed Last updated 18 November 2023

What this trial tests

trial testing Neck ultrasound in Tracheostomy Complication in 500 participants. Completed in 13 November 2023.

Timeline

14 August 2023

Primary endpoint
13 November 2023

13 November 2023

Quick facts

Lead sponsor	University of Padova
Status	Completed
Study type	OBSERVATIONAL
Enrollment	500
Start date	14 August 2023
Primary completion	13 November 2023
Estimated completion	13 November 2023
Sites	1 location across Italy

Drugs / interventions tested

• Neck ultrasound

Conditions studied

• Tracheostomy Complication — all drugs for Tracheostomy Complication →
• Trachea — all drugs for Trachea →

Sponsor

University of Padova

Who can join

18 and older, any sex, with Tracheostomy Complication or Trachea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ultrasound mapping of soft tissue vascular anatomy proximal to the larynx: a prospective cohort study.
   De Cassai A, Iuzzolino M, De Pinto S, Zecchino G, et al · · 2024 · cited 2× · PMID 38653329 · DOI 10.4097/kja.23900