Ultrasound Scanning of Vascular Access Sites

Ultrasonography Clinical Trial

Official title:

Ultrasound Scanning of Vascular Access Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330837
• Other study ID #: 0512116
• Status: Completed
• Phase: Phase 1
• First received: May 26, 2006
• Last updated: February 7, 2008
• Start date: February 2006
• Est. completion date: February 2007

Study information

• Verified date: February 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheterization, Central Venous
• Ultrasonography

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Knoblanche GE. Respiratory obstruction due to haematoma following internal jugular vein cannulation. Anaesth Intensive Care. 1979 Aug;7(3):286. — View Citation

Kua JS, Tan IK. Airway obstruction following internal jugular vein cannulation. Anaesthesia. 1997 Aug;52(8):776-80. — View Citation

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. — View Citation

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. — View Citation