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Design the Home Care Platform for the Monitoring of A Hemodialysis Arteriovenous Graft by Intelligent Physiological Signal

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00702559
First received: June 18, 2008
Last updated: June 19, 2008
Last verified: June 2008
  Purpose

Most patients with end-stage renal disease require hemodialysis. An arteriovenous fistula (AVF) or a prosthetic arteriovenous graft (AVG) is the preferred accesses for this. After its surgical creation, the fistular vein immediately faces a tremendous blood flow and the venous lumen is gradually dilated and the wall thickened, producing an access that can be routinely needled and deliver sufficient blood flow for dialysis. However, many hemodialysis patients will experience access stenosis, dysfunction, and even thrombosis, which are the most common complications of a hemodialysis access.

Most physicians, in-charge nurses of the hemodialysis unit, patient, and/or the family use traditional stethoscope as a convenient method to evaluate the patency and function of a hemodialysis access before, during, and after each session of dialysis. The acoustic signal of an access is always affected by environmental noises, non-specific in nature, and the sensitivity to detect stenosis is very low.

With the development and use of electronic stethoscope, the proprietary ambient noise acoustically cancels out an average of 75% of distracting room noise, greatly enhancing overall utility. However, the output acoustic signals are still apprehended by the ear, which is the main source of bias and errors of detection.

Our study purpose is to apply the signal processing technology to transfer the acoustic signals into simple visual signals that provide an easy way to read. It can be used by a professional medical staff, a non-professional person responsible for taking care, or even the patient himself, disability or not, as an early screening detector of stenosis or dysfunction of a hemodialysis access.


Condition
Renal Dialysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 50
Study Start Date: January 2008
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

50 prosthetic dialysis accesses on upper extremities

Criteria

Inclusion Criteria:

  • prosthetic grafts with clinical signs of dysfunctions or malfunctions and were referred for angiographic evaluations.

Exclusion Criteria:

  • autologous arteriovenous accesses or known thrombosed accesses.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702559

Contacts
Contact: Chih-Yang Chan, MD, PhD 886-8966-7000 chanchihyang@mail.femh.org.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Chih-Yang Chan, MD, PhD    886-8966-7000    chanchihyang@mail.femh.org.tw   
Sponsors and Collaborators
Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00702559     History of Changes
Other Study ID Numbers: FEMH-96040
Study First Received: June 18, 2008
Last Updated: June 19, 2008
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on November 25, 2014