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

NCT02814721 | Completed Results

• 1 other identifier: 9462
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula, Cannulation

Outcome Measures

Primary Outcomes (1)

• Infiltration Due to Dialysis Access Cannulation

  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 Outcomes (1)

• Patient Pain Scale

  3 weeks from use of fistula

Study Arms (2)

Standard cannulation

NO INTERVENTION

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.

Ultrasound guided cannulation

ACTIVE COMPARATOR

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

Interventions

Sonic Window ultrasound device DEVICE

Ultrasound guided cannulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• End-stage renal disease with grafts

Sponsors & Collaborators

• Henry Ford Health System: lead
• Analogic Corporation: collaborator

Study Sites (1)

GHS West pavilion dialysis center

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lalathaksha Kumbar
• Organization: Henry Ford Hospital

lkumbar1@hfhs.org

3136271761

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior staff Physician

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 28, 2016
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)