Catheterization, Central VenousNCT00330837
Ultrasound Scanning of Vascular Access Sites
An observational study of Catheterization, Central Venous and Ultrasonography, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheterization, Central Venous, Ultrasonography
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects will be any person age 18 and older who can legally consent to being scanned by ultrasound
Who cannot join
- No exclusion criteria shall be based on race, ethnicity, gender, pregnancy status, or HIV status
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read the 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.
- Conditions
- Catheterization, Central Venous, Ultrasonography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Catheterization, Central VenousStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- George Stetten, MD/PhD, Principal investigator, University of Pittsburgh, Dept of Bioengineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330837
- Sponsor's protocol ID
- 0512116
- Status last verified
- Feb 2008
- First submitted
- 26 May 2006
- Last updated
- 15 Feb 2008
- Results posted
- No
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. doi: 10.1177/0310057X8201000103.
PubMed 7065401Patel 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.
PubMed 3943335Knoblanche GE. Respiratory obstruction due to haematoma following internal jugular vein cannulation. Anaesth Intensive Care. 1979 Aug;7(3):286. No abstract available.
PubMed 495941Kua 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.
PubMed 9291764Shield 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.
PubMed 1098191Gobeil 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.
PubMed 8291718Applebaum 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.
PubMed 9339427
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Scanning of Vascular Access Sites
- ClinicalTrials.gov ID
- NCT00330837
- Acronym / sponsor ID
- 0512116
- Conditions
- Catheterization, Central Venous, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 29 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subjects will be any person age 18 and older who can legally consent to being scanned by ultrasound
Key exclusion criteria (1 listed)
- No exclusion criteria shall be based on race, ethnicity, gender, pregnancy status, or HIV status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2008.
- Background: PubMed 7065401Davies 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.
- Background: PubMed 3943335Patel 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.
- Background: PubMed 495941Knoblanche GE. Respiratory obstruction due to haematoma following internal jugular vein cannulation. Anaesth Intensive Care. 1979 Aug;7(3):286. No abstract available.
- Background: PubMed 9291764Kua 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.
- Background: PubMed 1098191Shield 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.
- Background: PubMed 8291718Gobeil 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.
- Background: PubMed 9339427Applebaum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Stetten, MD/PhD principal investigator
University of Pittsburgh, Dept of Bioengineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheterization, Central Venous and Ultrasonography, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330837, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2008.