Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT02085486
First received: March 3, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Dialysis
Fistula
Device: Ultrasound-assisted puncture
Other: Standard

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients After a Short Learning Program in Bed-side Ultrasound for Hemodialysis Nurses by an Index Nurse - an Outcome Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Rate of successful cannulations of an AV-fistula [ Time Frame: Immediately after the cannulation, expected to be after 10 minutes on average ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Effective dialysis time [ Time Frame: Directly after the treatment, expected to be after 3 to 4.5 hours ] [ Designated as safety issue: No ]
    Measured in minutes

  • Processed volume [ Time Frame: Directly after the treatment, expected to be after 3 to 4.5 hours ] [ Designated as safety issue: No ]
  • Number of patients with late complications [ Time Frame: At the following dialysis session, expected to be after 2-3 days ] [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Measured by questionnaire


Estimated Enrollment: 90
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound-assisted puncture
Ultrasound-assisted puncture by the nursing staff of patients with difficult AV-shunts.
Device: Ultrasound-assisted puncture
Portable ultrasound device
Standard
Classical method wtih inspection and palpation
Other: Standard
Standard inspection, palpation.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085486

Contacts
Contact: Robert M Kalicki, MD +41316323144 robert.kalicki@mph.unibe.ch

Locations
Switzerland
Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern Not yet recruiting
Bern, Switzerland, 3010
Contact: Robert M Kalicki, MD    +41316323144    robert.kalicki@mph.unibe.ch   
Principal Investigator: Robert M Kalicki, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Robert M Kalicki, MD Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02085486     History of Changes
Other Study ID Numbers: SNCTP000000515
Study First Received: March 3, 2014
Last Updated: March 10, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
dialysis
av shunt
cannulation
ultrasound
outcome

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 11, 2014