Back to resultsCoronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique
Primary Purpose
Arteriovenous Fistula, Cannulation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonic Window ultrasound device
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula, Cannulation
Eligibility Criteria
Inclusion Criteria:
- End-stage renal disease with new arteriovenous fistula being started for cannulation
Exclusion Criteria:
- End-stage renal disease with grafts
Sites / Locations
- GHS West pavilion dialysis center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard cannulation
Ultrasound guided cannulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
infiltration due to dialysis access cannulation
Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis.
Secondary Outcome Measures
patient comfort
Measured using a scale of 1-10 with 10 being the most severe pain
Full Information
NCT ID
NCT02814721
First Posted
June 21, 2016
Last Updated
June 23, 2016
Sponsor
Henry Ford Health System
Collaborators
Analogic Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02814721
Brief Title
Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique
Official Title
Coronal Mode Ultrasound Guided Hemodialysis Cannulation: A Pilot Randomized Comparison With Standard Cannulation Technique
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Analogic Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula, Cannulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard cannulation
Arm Type
No Intervention
Arm Description
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.
Arm Title
Ultrasound guided cannulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sonic Window ultrasound device
Primary Outcome Measure Information:
Title
infiltration due to dialysis access cannulation
Description
Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis.
Time Frame
First nine dialysis sessions or 3 weeks from use of fistula which ever comes first.
Secondary Outcome Measure Information:
Title
patient comfort
Description
Measured using a scale of 1-10 with 10 being the most severe pain
Time Frame
First nine dialysis sessions or 3 weeks from use of fistula which ever comes first.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
End-stage renal disease with new arteriovenous fistula being started for cannulation
Exclusion Criteria:
End-stage renal disease with grafts
Facility Information:
Facility Name
GHS West pavilion dialysis center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique
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