NCT00330837

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

First QC Date

May 26, 2006

Last Update Submit

February 7, 2008

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (7)

  • 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. doi: 10.1177/0310057X8201000103.

    PMID: 7065401BACKGROUND
  • 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. doi: 10.1097/00003246-198603000-00005.

    PMID: 3943335BACKGROUND
  • Knoblanche GE. Respiratory obstruction due to haematoma following internal jugular vein cannulation. Anaesth Intensive Care. 1979 Aug;7(3):286. No abstract available.

    PMID: 495941BACKGROUND
  • Kua JS, Tan IK. Airway obstruction following internal jugular vein cannulation. Anaesthesia. 1997 Aug;52(8):776-80. doi: 10.1111/j.1365-2044.1997.177-az0310.x.

    PMID: 9291764BACKGROUND
  • 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.

    PMID: 1098191BACKGROUND
  • 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.

    PMID: 8291718BACKGROUND
  • 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. doi: 10.1016/s0894-7317(97)70119-6.

    PMID: 9339427BACKGROUND

Study Officials

  • George Stetten, MD/PhD

    University of Pittsburgh, Dept of Bioengineering

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

February 1, 2006

Study Completion

February 1, 2007

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations