Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients

NCT02085486 | Withdrawn

• 1 other identifier: SNCTP000000515
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The puncture of the vascular access in hemodialysis patients remains challenging even in the hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor patient satisfaction. The use of ultrasound by emergency department nurses and technicians without prior ultrasound experience in patients with difficult intravenous access showed in several studies to be very efficient. The investigators expect to achieve similar results in cannulation of AV shunts by the dialysis nurse staff after a short learning program. To show this, the investigators aim to conduct a trail where standard cannulation technique (inspection, palpation) will be compared with the ultrasound-assisted method in terms of efficacy, safety and patient satisfaction.

Conditions

Dialysis; Fistula

Keywords

dialysis; av shunt; cannulation; ultrasound; outcome

Outcome Measures

Primary Outcomes (1)

• Rate of successful cannulations of an AV-fistula

  Satisfactory puncture of the fistula defined as the ability to achieve a full length dialysis (max. 10% reduction of the usual dialysis time), double-needle, and the usual blood flow rate (max. 15% reduction of the usual blood flow)

  Immediately after the cannulation, expected to be after 10 minutes on average

Secondary Outcomes (4)

• Effective dialysis time

  Directly after the treatment, expected to be after 3 to 4.5 hours

• Processed volume

  Directly after the treatment, expected to be after 3 to 4.5 hours

• Number of patients with late complications

  At the following dialysis session, expected to be after 2-3 days

• Patient satisfaction

  Immediately after the canulation, expected to be after 10 minutes on average, and at the following dialysis session, expected to be after 2-3 days

Study Arms (2)

Ultrasound-assisted puncture

EXPERIMENTAL

Ultrasound-assisted puncture by the nursing staff of patients with difficult AV-shunts.

Device: Ultrasound-assisted puncture

Standard

OTHER

Classical method wtih inspection and palpation

Other: Standard

Interventions

Ultrasound-assisted puncture DEVICE

Portable ultrasound device

Ultrasound-assisted puncture

Standard OTHER

Standard inspection, palpation.

Standard

Eligibility Criteria

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

You may qualify if:

• Forearm or upper arm AV-shunt (native, mixed, graft)
• Patients with recognized difficult vascular access at any time (potentially each patient)
• Written informed consent

You may not qualify if:

• Recent AV-shunt surgery (\< 48 h)
• Presence of large bandages or severe skin lesions in the area of interest
• Inability to understand the aim of the study and to give a written informed consent
• Single needle

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Related Publications (5)

• Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc Nephrol. 1996 Apr;7(4):523-35. doi: 10.1681/ASN.V74523.

  PMID: 8724885 BACKGROUND

• Hakim R, Himmelfarb J. Hemodialysis access failure: a call to action. Kidney Int. 1998 Oct;54(4):1029-40. doi: 10.1046/j.1523-1755.1998.00122.x.

  PMID: 9767519 BACKGROUND

• Saudan P, Kossovsky M, Halabi G, Martin PY, Perneger TV; Western Switzerland Dialysis Study Group. Quality of care and survival of haemodialysed patients in western Switzerland. Nephrol Dial Transplant. 2008 Jun;23(6):1975-81. doi: 10.1093/ndt/gfm915. Epub 2007 Dec 22.

  PMID: 18156654 BACKGROUND

• Brannam L, Blaivas M, Lyon M, Flake M. Emergency nurses' utilization of ultrasound guidance for placement of peripheral intravenous lines in difficult-access patients. Acad Emerg Med. 2004 Dec;11(12):1361-3. doi: 10.1197/j.aem.2004.08.027.

  PMID: 15576530 BACKGROUND

• Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.

  PMID: 19371518 BACKGROUND

MeSH Terms

Conditions

Fistula; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert M Kalicki, MD

  Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 12, 2014
• Study Start: August 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 30, 2023

Record last verified: 2023-01