Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique

February 28, 2024 updated by: Lalathaksha Kumbar, Henry Ford Health System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GHS West pavilion dialysis center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • End-stage renal disease with grafts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard cannulation
The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions.
Active Comparator: Ultrasound guided cannulation
The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula.
Device: Sonic Window ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks from use of fistula

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Pain Scale
Time Frame: 3 weeks from use of fistula
Measured using a scale of 1-10 with 10 being the most severe pain
3 weeks from use of fistula

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Analogic Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimated)

June 28, 2016

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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