Arteriovenous Fistula, Cannulation
Conditions
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.
Interventions
DEVICESonic Window ultrasound device
Sponsors
Analogic Corporation
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* End-stage renal disease with new arteriovenous fistula being started for cannulation
Exclusion criteria
* End-stage renal disease with grafts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infiltration Due to Dialysis Access Cannulation | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Scale | 3 weeks from use of fistula | Measured using a scale of 1-10 with 10 being the most severe pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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.
Sonic Window ultrasound device | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Total | Standard Cannulation | Ultrasound Guided Cannulation |
|---|---|---|---|
| Age, Continuous | 61.5 years | 52.5 years | 66 years |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
Infiltration Due to Dialysis Access Cannulation
Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis.
Time frame: 3 weeks from use of fistula
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Cannulation | Infiltration Due to Dialysis Access Cannulation | 5 infiltration events |
| Ultrasound Guided Cannulation | Infiltration Due to Dialysis Access Cannulation | 7 infiltration events |
Secondary
Patient Pain Scale
Measured using a scale of 1-10 with 10 being the most severe pain
Time frame: 3 weeks from use of fistula
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Cannulation | Patient Pain Scale | 2.1 score on a scale | Standard Deviation 2 |
| Ultrasound Guided Cannulation | Patient Pain Scale | 2.6 score on a scale | Standard Deviation 1.8 |