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Ultrasound Scanning of Vascular Access Sites
This study has been completed.
Sponsored by: University of Pittsburgh
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00330837
  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 I

MedlinePlus related topics: Nuclear Scans Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Ultrasound Scanning of Vascular Access Sites

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:
Davies MJ, Cronin KD, Domaingue CM. Pulmonary artery catheterisation. An assessment of risks and benefits in 220 surgical patients. Anaesth Intensive Care. 1982 Feb;10(1):9-14.
Patel C, Laboy V, Venus B, Mathru M, Wier D. Acute complications of pulmonary artery catheter insertion in critically ill patients. Crit Care Med. 1986 Mar;14(3):195-7.
Knoblanche GE. Respiratory obstruction due to haematoma following internal jugular vein cannulation. Anaesth Intensive Care. 1979 Aug;7(3):286. No abstract available.
Kua JS, Tan IK. Airway obstruction following internal jugular vein cannulation. Anaesthesia. 1997 Aug;52(8):776-80.
Shield CF 3rd, Richardson JD, Buckley CJ, Hagood CO Jr. Pseudoaneurysm of the brachiocephalic arteries: a complication of percutaneous internal jugular vein catheterization. Surgery. 1975 Aug;78(2):190-4.
Shield CF 3rd, Richardson JD, Buckley CJ, Hagood CO Jr. Pseudoaneurysm of the brachiocephalic arteries: a complication of percutaneous internal jugular vein catheterization. Surgery. 1975 Aug;78(2):190-4.
Gobeil F, Couture P, Girard D, Plante R. Carotid artery-internal jugular fistula: another complication following pulmonary artery catheterization via the internal jugular venous route. Anesthesiology. 1994 Jan;80(1):230-2. No abstract available.
Applebaum RM, Adelman MA, Kanschuger MS, Jacobowitz G, Kronzon I. Transesophageal echocardiographic identification of a retrograde dissection of the ascending aorta caused by inadvertent cannulation of the common carotid artery. J Am Soc Echocardiogr. 1997 Sep;10(7):749-51.

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

ClinicalTrials.gov processed this record on January 15, 2009