Ultrasound Scanning of Vascular Access Sites

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00330837
First received: May 26, 2006
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

Inadvertent puncture of an unintended object in a vascular access procedure is common and can lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while targeting the internal jugular vein (IJV), for example, is reported to have an incidence of 2% - 8% and usually results in localized hematoma formation. The hematoma may enlarge rapidly if the patient is coagulopathic, or if a large puncture wound is produced by the introduction of the sheath itself into the CCA. Airway obstruction, pseudoaneurysm, arterio-venous fistula formation and retrograde aortic dissection have all been reported as a consequence of CCA puncture. In the presence of occlusive (atheromatous) carotid disease, inadvertent puncture may carry the risk of precipitating a cerebrovascular accident.

In this study, we aim to collect color Doppler and B-mode ultrasound videos from the most common ultrasound-guided vascular access sites - internal jugular vein, subclavian vein, femoral vein, basilic vein, and brachial vein. The videos will also include structures in close proximity to the intended veins. Using such database, we will run various vessel tracking and identification algorithms to evaluate their performance. Our ultimate goal is to develop an algorithm that will aid the ultrasound operator in identifying structures and differentiating between arteries and veins.


Condition Phase
Catheterization, Central Venous
Ultrasonography
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ultrasound Scanning of Vascular Access Sites

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 100
Study Start Date: February 2006
Study Completion Date: February 2007
Detailed Description:

Inadvertent puncture of an unintended object in a vascular access procedure is common and can lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while targeting the internal jugular vein (IJV), for example, is reported to have an incidence of 2% - 8% and usually results in localized hematoma formation. The hematoma may enlarge rapidly if the patient is coagulopathic, or if a large puncture wound is produced by the introduction of the sheath itself into the CCA. Airway obstruction, pseudoaneurysm, arterio-venous fistula formation and retrograde aortic dissection have all been reported as a consequence of CCA puncture. In the presence of occlusive (atheromatous) carotid disease, inadvertent puncture may carry the risk of precipitating a cerebrovascular accident.

In this study, we aim to collect color Doppler and B-mode ultrasound videos from the most common ultrasound-guided vascular access sites - internal jugular vein, subclavian vein, femoral vein, basilic vein, and brachial vein. The videos will also include structures in close proximity to the intended veins. Using such database, we will run various vessel tracking and identification algorithms to evaluate their performance. Our ultimate goal is to develop an algorithm that will aid the ultrasound operator in identifying structures and differentiating between arteries and veins.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subjects will be any person age 18 and older who can legally consent to being scanned by ultrasound

Exclusion Criteria:

  • No exclusion criteria shall be based on race, ethnicity, gender, pregnancy status, or HIV status
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330837

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: George Stetten, MD/PhD University of Pittsburgh, Dept of Bioengineering
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00330837     History of Changes
Other Study ID Numbers: 0512116
Study First Received: May 26, 2006
Last Updated: February 7, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013