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Clinical Trials/NCT02814721
NCT02814721
Completed
Not Applicable

Coronal Mode Ultrasound Guided Hemodialysis Cannulation: A Pilot Randomized Comparison With Standard Cannulation Technique

Henry Ford Health System1 site in 1 country10 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arteriovenous Fistula, Cannulation
Sponsor
Henry Ford Health System
Enrollment
10
Locations
1
Primary Endpoint
Infiltration Due to Dialysis Access Cannulation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lalathaksha Kumbar

Senior staff Physician

Henry Ford Health System

Eligibility Criteria

Inclusion Criteria

  • End-stage renal disease with new arteriovenous fistula being started for cannulation

Exclusion Criteria

  • End-stage renal disease with grafts

Outcomes

Primary Outcomes

Infiltration Due to Dialysis Access Cannulation

Time Frame: 3 weeks from use of fistula

Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis.

Secondary Outcomes

  • Patient Pain Scale(3 weeks from use of fistula)

Study Sites (1)

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