Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381310
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-09
Brief Title:
Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with ESRD are able to maintain life by undergoing renal replacement therapy including hemodialysis HD peritoneal dialysis PD or kidney transplantation HD continues to be the primary option Arteriovenous fistula AVF and arteriovenous graft AVG are the common access sites for hemodialysis HD patients AVF is the best access for dialysis which is known as the lifeline of hemodialysis patients but requires 6 to 8 weeks to maturate Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly With increasing AVF prevalence as well as aging and more obese populations in the developed world increasing numbers of difficult-to-cannulate AVFs are being encountered in practice
Traditionally after maturation cannulation of new AVFAVG was performed by trained renal nurses through physical examination namely listening to bruits and feeling for thrills to guide needle placement known as blind cannulatio However physical examination is not reliable for first and difficult access cannulation eg small or partial stenosis deep-seated AVFAVG presence of clots after multiple failed attempts with hematoma swelling andor immature access with small vessel caliber rendered higher rate of cannulation failure and lower AVF and AVG survival Unfortunately cannulation failure result in access damage vessel intimal lining damage leading to stenosis thrombosis or aneurysm formation contributing to AVF failure treatment delay and increased requirement for central venous access devices CVAD Patients with early AVF failure have much higher mortality risk particularly if they are older and female Van Loon et al revealed that up to 90 of the first cannulation had complications ie infiltration including hematoma formation and missed cannulation With a high rate of AVF maturation failure 38-60 in general cannulation failure may be avoidable if a more in-depth assessment was done before the attempt
Ultrasound US guided cannulation effective in identifying access location and patency Roshan et al reported a case study on bedside ultrasonography for AVF cannulation The study showed decreased cannulation failure vessel wall damage thrombosis and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation
Therefore this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care
Traditionally after maturation cannulation of new AVFAVG was performed by trained renal nurses through physical examination namely listening to bruits and feeling for thrills to guide needle placement known as blind cannulatio However physical examination is not reliable for first and difficult access cannulation eg small or partial stenosis deep-seated AVFAVG presence of clots after multiple failed attempts with hematoma swelling andor immature access with small vessel caliber rendered higher rate of cannulation failure and lower AVF and AVG survival Unfortunately cannulation failure result in access damage vessel intimal lining damage leading to stenosis thrombosis or aneurysm formation contributing to AVF failure treatment delay and increased requirement for central venous access devices CVAD Patients with early AVF failure have much higher mortality risk particularly if they are older and female Van Loon et al revealed that up to 90 of the first cannulation had complications ie infiltration including hematoma formation and missed cannulation With a high rate of AVF maturation failure 38-60 in general cannulation failure may be avoidable if a more in-depth assessment was done before the attempt
Ultrasound US guided cannulation effective in identifying access location and patency Roshan et al reported a case study on bedside ultrasonography for AVF cannulation The study showed decreased cannulation failure vessel wall damage thrombosis and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation
Therefore this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None