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

Not Applicable

Completed

• Conditions: Arteriovenous Fistula, Cannulation
• Interventions: Device: Sonic Window ultrasound device

• Registration Number: NCT02814721
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Results First Submitted: 2022-12-07
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Results First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• End-stage renal disease with grafts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided cannulation	Sonic Window ultrasound device	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient Pain Scale	3 weeks from use of fistula	Measured using a scale of 1-10 with 10 being the most severe pain

Trial Locations

Locations (1)

GHS West pavilion dialysis center; 🇺🇸 Detroit, Michigan, United States