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Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients

This study is not yet open for participant recruitment.
Verified June 2017 by University Hospital Inselspital, Berne
Sponsor:
ClinicalTrials.gov Identifier:
NCT02085486
First Posted: March 12, 2014
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    Measured in minutes

  • Processed volume [ Time Frame: Directly after the treatment, expected to be after 3 to 4.5 hours ]
  • Number of patients with late complications [ Time Frame: At the following dialysis session, expected to be after 2-3 days ]
  • 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 ]
    Measured by questionnaire


Estimated Enrollment: 90
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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