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OpenTrials
Completed

NCT Number: NCT02814721

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHS West pavilion dialysis center

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • End-stage renal disease with grafts

Treatment and study plan

Sonic Window ultrasound device

Device

Primary outcomes

  1. Infiltration Due to Dialysis Access Cannulation

    Time frame: 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 outcomes

  1. Patient Pain Scale

    Time frame: 3 weeks from use of fistula

    Measured using a scale of 1-10 with 10 being the most severe pain

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Analogic Corporation

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 28, 2016
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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