Clinical Trial: Electro Stethoscope in Detect Arteriovenous Fistula (AVF) Stenosis
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: Electronic Stethoscope and Computer-aided Diagnostic System in Detecting Arteriovenous Fistula (AVF) Stenosis
Brief Summary: The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan are both the highest worldwide from 2001 to 2008. In Taiwan, more than 90% of the ESRD patients are hemodialysis patients. Either arteriovenous fistula (AVF) or arteriovenous graft (AV graft) is essential for the vascular access of these patients. However, frequent AVF stenosis or thrombosis occurs in 10-30% hemodialytic patients, and the rates are even higher, around 30-70%, in those who has a past history of AVF/AV graft stenosis. Therefore, early detection of AVF stenosis is essential in caring for these hemodialysis patients in terms of medical economics and psychological impact. Unfortunately, angiographic study is expensive and invasive and needs contrast medium injection. The diagnostic accuracy of color duplex ultrasound in AVF stenosis remains satisfactory, but it is not always available when decreased AVF flow or an acute thrombotic event occurs. Continuous AVF/ AV graft flow monitoring by patient himself is a better option in terms of long-term care. Previous study indicated that stethoscope waveform analysis could be used as an alternative to diagnosis of vascular stenosis. Therefore, we aim to investigate AVF/ AV graft stenosis by using the electronic stethoscope (3M Littmann) for AVF sound recording, followed by software analysis by using waveform decomposition, principle component analysis (PCA) and sequential forward selection algorithm [xx]. Our study results will provide a new diagnostic option, which is low cost, non-invasive and self-monitoring, of AVF stenosis in ESRD patients.
Detailed Summary:
Hemodialysis is a well-established method for removal of fluid and uremic toxins and prolonging survival in patients with end-stage renal disease (ESRD). The most common permanent vascular assesses are autogenous and non-autogenous arteriovenous (AV) fistula, referred as AV fistula and AV graft, respectively. In Taiwan, both incidence and prevalence of ESRD remain highest worldwide. However, frequent vascular stenosis/ thrombosis events occurred because of repeated needle punctures. These will exert a large economic burden to our society and psychological impacts on ESRD patients [1]. Therefore, it is essential to develop an easy and patient-centered method to monitor the flow status in either AV fistula or AV graft.
Physical examination and auscultation are simple monitoring methods to assess the vascular access. There were several signs reported to be associated vascular stenosis, such as prolonged bleeding, arm edema, and changes in pulse characteristics of the vascular access, but they need a high level of skill and experience from the operator, such as doctors and nurses [2].
Unfortunately, angiographic study is expensive and invasive and needs contrast medium injection. The diagnostic accuracy of color duplex ultrasound in AVF stenosis remains satisfactory, but it is not always available when decreased AVF flow or an acute thrombotic event occurs. Continuous AVF/ AV graft flow monitoring by patient himself is a better option in terms of long-term care. Previous study indicated that stethoscope waveform analysis could be used as an alternative to diagnosis of vascular stenosis. Previous acoustic studies indicated that increased sound intensity, extra sounds, and higher spectral energy infrequency domain, ranging between 300 Hz and 1000 Hz. These findings are associated with the change from laminar flow to turbulent fl
Sponsor: National Taiwan University Hospital
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Taiwan University Hospital
Dates:
Date Received: January 15, 2012
Date Started: January 2012
Date Completion: December 2012
Last Updated: January 18, 2012
Last Verified: January 2012
