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

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ClinicalTrials.gov Identifier: NCT00702559
Recruitment Status : Unknown
Verified June 2008 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2008
Last Update Posted : June 20, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease
Renal Dialysis

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00702559     History of Changes
Other Study ID Numbers: FEMH-96040
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: June 2008