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

Arteriovenous Fistula, Cannulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814721
• Other study ID #: 9462
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• End-stage renal disease with grafts

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula, Cannulation
• Fistula

Intervention

Device:
• Sonic Window ultrasound device

Locations

Country	Name	City	State
United States	GHS West pavilion dialysis center	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Analogic Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 weeks from use of fistula
Secondary	Patient Pain Scale	Measured using a scale of 1-10 with 10 being the most severe pain	3 weeks from use of fistula