Ignite Creation Date:
2025-12-18 @ 8:19 AM
Ignite Modification Date:
2025-12-23 @ 11:16 PM
Study NCT ID:
NCT03027323
Status:
None
Last Update Posted:
2022-10-28 00:00:00
First Post:
2017-01-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Washington Study of AxoTrack-Guided Central Venous Cannulation
Sponsor:
None
Organization:
Study Overview
Official Title:
Washington Study of AxoTrack-Guided Central Venous Cannulation
Status:
None
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not funded; no participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WASHCAN
Brief Summary:
Central venous cannulation (CVC) is commonly performed to give volume resuscitation and parenteral medications to patients with time sensitive conditions such as severe traumatic injury or undifferentiated shock. CVC via the subclavian route is associated with more frequent technical complications but less frequent infection or thrombosis as compared with via the internal jugular or femoral veins. Traditionally CVC via the subclavian vein is guided by anatomical landmarks. CVC guided by real-time use of traditional diagnostic ultrasound device is associated with a lower technical failure rate (overall and on first attempt), fewer punctures, faster access, and fewer mechanical complications as compared with guidance by anatomical landmarks when performed via the internal jugular vein. It remains unclear whether CVC guided by real-time ultrasound is associated with significantly lower failure and complication rates as compared with CVC guided by landmarks when performed via the subclavian vein. CVC guided by real-time ultrasound may reduce the incidence of complications, number of punctures, and the time between skin penetration and the aspiration of venous blood into the syringe as compared with guidance by landmarks. A limitation of guidance by a traditional diagnostic ultrasound device is it that it may require an assistant to perform, which may not be feasible when treating time sensitive conditions or in low resource settings. In addition, most traditional ultrasound probes are not designed to image the subclavian vein behind the clavicle. The AxoTrack system is a novel ultrasound guidance system recently cleared for human use by the United States Food and Drug Administration. It is intended to facilitate CVC by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein. It remains unclear whether CVC guided by AxoTrack reduces procedure times and complication rates when compared with CVC using landmark guidance in patients with undifferentiated hypotension.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: