DialysisNCT02085486
Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients
A study testing Ultrasound-assisted puncture and Standard in people with Dialysis and Fistula, run by Insel Gruppe AG, University Hospital Bern.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ultrasound-assisted puncture and Standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forearm or upper arm AV-shunt (native, mixed, graft)
- Patients with recognized difficult vascular access at any time (potentially each patient)
- Written informed consent
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Being tested
- Ultrasound-assisted puncture, Standard
- Keywords
- dialysis, av shunt, cannulation, ultrasound, outcome
- Medical subject headings
- Fistula, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-assisted punctureDevice
Portable ultrasound device
StandardOther
Standard inspection, palpation.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-assisted puncture | Experimental | Ultrasound-assisted puncture by the nursing staff of patients with difficult AV-shunts. Receives: Device: Ultrasound-assisted puncture |
| Standard | Other | Classical method wtih inspection and palpation Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately after the cannulation, expected to be after 10 minutes on average
Secondary outcomes (4)
Effective dialysis time
Measured in minutes
Measured: Directly after the treatment, expected to be after 3 to 4.5 hours
Processed volume
Measured: Directly after the treatment, expected to be after 3 to 4.5 hours
Number of patients with late complications
Measured: At the following dialysis session, expected to be after 2-3 days
Patient satisfaction
Measured by questionnaire
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startAug 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Lack of scientific interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M Kalicki, MD, Principal investigator, Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085486
- Sponsor's protocol ID
- SNCTP000000515
- Status last verified
- Jan 2023
- First submitted
- 3 Mar 2014
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8724885Hakim 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.
PubMed 9767519Saudan 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.
PubMed 18156654Brannam 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.
PubMed 15576530Bauman 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.
PubMed 19371518
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02085486
- Acronym / sponsor ID
- SNCTP000000515
- Keywords
- dialysis, av shunt, cannulation, ultrasound, outcome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of scientific interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted puncture | Experimental | Device: Ultrasound-assisted punctureUltrasound-assisted puncture by the nursing staff of patients with difficult AV-shunts. |
| Standard | Other | Other: StandardClassical method wtih inspection and palpation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Forearm or upper arm AV-shunt (native, mixed, graft)
- Patients with recognized difficult vascular access at any time (potentially each patient)
- Written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-assisted puncturePortable ultrasound device | Device | Ultrasound-assisted puncture |
| StandardStandard inspection, palpation. | Other | Standard |
Primary outcome
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)
4 secondary outcomes
Effective dialysis time
Time frame: Directly after the treatment, expected to be after 3 to 4.5 hours
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 8724885Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc Nephrol. 1996 Apr;7(4):523-35. doi: 10.1681/ASN.V74523.
- Background: PubMed 9767519Hakim 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.
- Background: PubMed 18156654Saudan 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.
- Background: PubMed 15576530Brannam 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.
- Background: PubMed 19371518Bauman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Kalicki, MD principal investigator
Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-assisted puncture and Standard in people with Dialysis and Fistula, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful cannulations of an AV-fistula (time frame: Immediately after the cannulation, expected to be after 10 minutes on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085486, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.