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Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients

Primary Purpose

Dialysis, Fistula

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-assisted puncture
Standard
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dialysis focused on measuring dialysis, av shunt, cannulation, ultrasound, outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Ultrasound-assisted puncture

    Standard

    Arm Description

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

    Classical method wtih inspection and palpation

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Effective dialysis time
    Measured in minutes
    Processed volume
    Number of patients with late complications
    Patient satisfaction
    Measured by questionnaire

    Full Information

    First Posted
    March 3, 2014
    Last Updated
    January 26, 2023
    Sponsor
    Insel Gruppe AG, University Hospital Bern
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02085486
    Brief Title
    Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of scientific interest
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    May 2018 (Anticipated)
    Study Completion Date
    May 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Insel Gruppe AG, University Hospital Bern

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Background The vascular access plays a central role in patients with end-stage renal disease undergoing chronic hemodialysis. It is well documented from various previous studies that the confection of the dialysis access and subsequent complications represent a major cause of morbidity, hospitalization and additional costs in chronic dialysis patients. In European countries most patients undergoing chronic hemodialysis use an arterio-venous fistula as permanent vascular access. Because of the anatomical differences of each individual and the accompanying chronic diseases affecting patients' vessels, cannulation of arterio-venous fistulas can be very challenging for the nursing personal and puncture failures necessitating repeated attempts are not so rare. The latter are often time-consuming and result in a loss of effective dialysis' time and reduced proceeded total blood volume, are associated with a higher rate of local complications due to repeated traumatisms of the vascular wall and can lead to severe pain with reduced patient satisfaction. In the investigators' dialysis unit, when a dialysis nurse is not able to puncture a fistula she refers to an experienced nurse who tries to cannulate the fistula after thorough visual and palpatory evaluation. In case of another failure, the nursing team refers to the dialysis physician, who performs a short diagnostic bed-side ultrasound of the vascular access to rule out the presence of thrombosis or large hematoma. Using ultrasound-guidance provided by the physician or after being informed about the localization and depth of the ideal puncture site, the dialysis nurse tries then to puncture the fistula again. This often leads to a greater loss of time with reduced effective dialysis dose, increased need for human resources and low 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 method was safe, the procedure rapid, the patients more satisfied, the success rate as high as this from ultrasound trained emergency physicians and the need for physician intervention reduced. The achievement of similar results in AV fistula cannulation in hemodialysis patients would be very suitable. The use of ultrasound in patients with recognized difficult fistulas by dialysis nurses after a short ultrasound learning program provided by an index nurse will enable to achieve a higher rate of satisfactory double-needle punctures, usual blood flow rates and full dialysis length with less time loss and increased patient satisfaction. With this study prospective, single-centre, randomized, controlled study the investigators aim to show that the use of ultrasound by dialysis nurses in patients with difficult fistulas makes the punction of the fistulas easier than when assessing the fistula visually and manually. Objective The use of ultrasound in patients with recognized difficult fistulas by dialysis nurses after a short ultrasound learning program provided by an index nurse will enable to achieve a higher rate of satisfactory double-needle punctures, usual blood flow rates and full dialysis length with less time loss and increased patient satisfaction. With a prospective, controlled trail the investigators want to demonstrate this hypothesis. Methods A portable ultrasound device will be used by the nursing staff after a short learning program. Precise location of AV shunt segments and depth will be assessed in the case of a difficult shunt. This procedure will be compared with the standard inspection and palpation method.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dialysis, Fistula
    Keywords
    dialysis, av shunt, cannulation, ultrasound, outcome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound-assisted puncture
    Arm Type
    Experimental
    Arm Description
    Ultrasound-assisted puncture by the nursing staff of patients with difficult AV-shunts.
    Arm Title
    Standard
    Arm Type
    Other
    Arm Description
    Classical method wtih inspection and palpation
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound-assisted puncture
    Intervention Description
    Portable ultrasound device
    Intervention Type
    Other
    Intervention Name(s)
    Standard
    Intervention Description
    Standard inspection, palpation.
    Primary Outcome Measure Information:
    Title
    Rate of successful cannulations of an AV-fistula
    Description
    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)
    Time Frame
    Immediately after the cannulation, expected to be after 10 minutes on average
    Secondary Outcome Measure Information:
    Title
    Effective dialysis time
    Description
    Measured in minutes
    Time Frame
    Directly after the treatment, expected to be after 3 to 4.5 hours
    Title
    Processed volume
    Time Frame
    Directly after the treatment, expected to be after 3 to 4.5 hours
    Title
    Number of patients with late complications
    Time Frame
    At the following dialysis session, expected to be after 2-3 days
    Title
    Patient satisfaction
    Description
    Measured by questionnaire
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert M Kalicki, MD
    Organizational Affiliation
    Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8724885
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9767519
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18156654
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15576530
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19371518
    Citation
    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.
    Results Reference
    background

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    Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients

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