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Withdrawn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
About this trial
This is an interventional supportive care trial for Dialysis focused on measuring dialysis, av shunt, cannulation, ultrasound, outcome
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
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
NCT ID
NCT02085486
First Posted
March 3, 2014
Last Updated
January 26, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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Withdrawn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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