Arteriovenous Fistula CannulationPafusGuCNCT05556915
Benefit of Ultrasound Guidance in Arteriovenous Fistula (AVF) Cannulation in Pediatric Hemodialysis
A study testing Ultrasound-guided AVF cannulation method and Conventional AVF cannulation method in people with Arteriovenous Fistula Cannulation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The arteriovenous fistula (AVF) is the reference hemodialysis vascular access for both adult and pediatric patients. The cannulation quality is decisive for the quality of the dialysis. Difficult AVF cannulations are more frequent in pediatrics than in adults. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Arteriovenous Fistula Cannulation
- What is being tested?
- Ultrasound-guided AVF cannulation method and Conventional AVF cannulation method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2022to 8 Apr 2024
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients ˂ 18 years of age at enrollment
- Patients with end-stage renal disease undergoing hemodialysis therapy
- Patients carrying an arteriovenous fistula created more than 6 weeks before enrollment
- Prior agreement of the patient and their legal representative by signing the parent's informed consent form
- Patients affiliated to social security system
Who cannot join
- Non-matured arteriovenous fistula according to the referring pediatrician
- Patients undergoing dialysis at least partly through a central venous catheter
- Estimated duration of dialysis less than 1 month in the investigation center
- Participation in other intervention research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intérêt De L'échoguidage Dans Les Ponctions De Fistule Artério-veineuse En Hémodialyse Pédiatrique
The arteriovenous fistula (AVF) is the reference hemodialysis vascular access for both adult and pediatric patients. The cannulation quality is decisive for the quality of the dialysis. Difficult AVF cannulations are more frequent in pediatrics than in adults. Recent studies in adults have shown that ultrasound-guided AVF cannulation improves the cannulation quality and therefore the quality of dialysis. This study aims to prove that ultrasound-guided AVF cannulation in children will improve the quality of dialysis overall.
Read the detailed description
The European and American recommandations emphasize that the arteriovenous fistula (AVF) is the first choice vascular access in hemodialysis for both adult and pediatric patients. Indeed, infections and thrombotic complications are lower with an AVF than with a central venous catheter. In addition, the efficiency of dialysis is better in patients with AVF in both pediatric and adult patients.
The pediatric population has its own characteristics. On the one hand, the size of the vessels, in particular in patients weighing less than 20 kilos, complicates the creation of the AVF. On the other hand, the time for AVF maturation in children (corresponding to the time required between the creation of the AVF and its use) is much higher than that of the adult population. These specific anatomical characteristics partly explain the more frequent AVF cannulation difficulties in pediatric patients.
Inadequate dialysis is considered to be a session in which the therapy goals were not achieved. This rate of inadequate dialysis is estimated at 8-10% in children due to vascular access problem, whereas this rate is only 1 to 5% in adults. There is also an increase in side effects related to these pediatric AVF cannulation difficulties (trauma, hematoma, edema following diffusion, etc.) responsible for inadequate dialysis and, in the long term, AVF dysfunction (stenosis, thrombosis).
The preservation of the vascular access by means of new cannulation techniques aimed at limiting trauma is therefore a primary objective in pediatric hemodialysis. The introduction of new cannulation methods as well as the training of nurses/childcare workers in the various puncture techniques would thus make it possible to improve the quality of dialysis sessions, the lifespan of AVFs, to increase the number of puncture sites and reduce the number of punctures per session and the occurrence of complications.
Recently, the ultrasound-guided AVF cannulation technique has shown promising results in adults with regard to the prevention of vascular access complications, the feeling of pain and the obtaining of adequate dialysis.
A recent review points to the need to confirm the benefit of ultrasound-guided cannulation through randomized studies, the current data being promising but needing to be confirmed. To date, no data concerning the benefit of ultrasound-guided cannulation in pediatrics is available in the literature. Our project will therefore be the first research to compare 2 AVF cannulation methods in pediatric hemodialysis. The hypothesis adopted is that the AVF cannulation using ultrasound guidance in children undergoing dialysis will allow an overall improvement of dialysis quality, a reduction of complication occurrence and an improvement of patient comfort.
- Conditions
- Arteriovenous Fistula Cannulation
- Being tested
- Ultrasound-guided AVF cannulation method, Conventional AVF cannulation method
- Keywords
- Arteriovenous fistula AVF, Pediatric hemodialysis, Cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided AVF cannulation methodOther
For ultrasound-guided cannulation, the same ultrasound device will be used for all patients (TE5-POC ultrasound MINDRAY® system). The ultrasound device will identify the AVF aspect , the location including the depth (distance from the skin surface) , the vessel diameter and guide the cannulation in real-time. The device will be disinfected between uses and covered with a transparent adhesive film to avoid any direct contact with the patient. Sterile gel will be used for the cannulation.
Conventional AVF cannulation methodOther
The AVF cannulation is carried out by palpation. This technique consists of manually evaluating the position, direction and depth of the fistula in order to determine the puncture site where the 2-dialysis catheters will be inserted. After local asepsis, the AVF is therefore needled at 2 points 5 cm apart.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided AVF cannulation method | Experimental | The AVF cannulation is carried out using ultrasoud guidance Receives: Other: Ultrasound-guided AVF cannulation method |
| Conventional AVF cannulation method | Other | The AVF cannulation is carried out by palpation Receives: Other: Conventional AVF cannulation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the rate of inadequate dialysis after ultrasound-guided AVF cannulation vs. conventional cannulation in pediatric patients (<18 years) with end-stage renal disease undergoing hemodialysis therapy.
Inadequate dialysis is defined by the presence of one of the following parameters:
- Blood flow rate (BFR expressed in ml/min corresponding to the volume of blood in milliliters that flows per minute) less than 80% of adequate blood flow corresponding to a flow ≥ 7 ml per kilograms of weight with a maximum of 300 ml/min
- Requirement of single-needle dialysis after 3 cannulation failures
- Early discontinuation of hemodialysis
- Loss of dialysis circuit during the session
- Out of range arterial or venous pressure during dialysis requiring a drop in blood flow rate
- Purification coefficient defined by Kt/V <1.2: K represents the dialyzer clearance of urea (expressed in milliliters/ min and corresponds to the volume of blood in ml cleared of urea per minute ) // t (in minutes) represents the dialysis time duration // V (in milliliters) represents the volume of distribution of urea, and equals the patient's total body water
Measured: 12 months
Secondary outcomes (7)
Number of cannulations required for the insertion of the 2 dialysis catheters
Compare the number of cannulations required for the insertion of the 2 dialysis catheters in conventional method vs ultrasound-guided method
Measured: During procedure
The time required for the insertion of the 2 catheters
Compare the time required for the insertion of the 2 catheters in conventional method vs ultrasound-guided method
Measured: During procedure
The occurrence of cannulation complications
Compare the occurrence of cannulation complications (hematoma, diffusion, aneurysm, etc.) in conventional method vs ultrasound-guided method
Measured: During procedure
The occurrence of dialysis incidents caused by catheters dysfunction
Compare the occurrence of dialysis incidents caused by catheters dysfunction (decrease in dialysis flow, single-puncture dialysis, shortening of dialysis time, loss of circuit) in conventional method vs ultrasound-guided method
Measured: During procedure
Patient satisfaction
Compare the patient satisfaction in conventional method vs ultrasound-guided method using a satisfaction questionnaire
Measured: 30 days, 90 days, 180 days and 12 months after enrollment
Patient comfort
Compare the patient comfort in conventional method vs ultrasound-guided method. The visual analogue scale (VAS) will be used by patients > 5 years of age. The VAS measures from 0 to 10 the intensity of pain. The higher the score the less comfortable the procedure
Measured: During the procedure
Patient comfort
Compare the patient comfort in conventional method vs ultrasound-guided method. The neonatal pain and discomfort scale (EDIN Échelle Douleur Inconfort Nouveau-Né ) will be used by patients ≤ 5 years of age.
The EDIN scale uses five behavioural indicators of pain: facial activity, body movements, quality of sleep, quality of contact with nurses, and consolability.
The scale measures friom 0 to 15 the intensity of pain. The higher the score the less comfortable the procedure
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start3 Dec 2022
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula CannulationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, randomized clinical study comparing two AVF cannulation methodes (conventional vs ultrasound-guided method) in pediatric patients with end-stage renal disease undergoing hemodialysis therapy.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Philippe BOUDET, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556915
- Sponsor's protocol ID
- RECHMPL21_0526
- Acronym
- PafusGuC
- Status last verified
- Jan 2025
- First submitted
- 13 Sep 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt De L'échoguidage Dans Les Ponctions De Fistule Artério-veineuse En Hémodialyse Pédiatrique
- ClinicalTrials.gov ID
- NCT05556915
- Acronym / sponsor ID
- PafusGuC / RECHMPL21_0526
- Conditions
- Arteriovenous Fistula Cannulation
- Keywords
- Arteriovenous fistula AVF, Pediatric hemodialysis, Cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 27 Sep 2022 (actual)
- 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 arteriovenous fistula (AVF) is the reference hemodialysis vascular access for both adult and pediatric patients. The cannulation quality is decisive for the quality of the dialysis. Difficult AVF cannulations are more frequent in pediatrics than in adults. Recent studies in adults have shown that ultrasound-guided AVF cannulation improves the cannulation quality and therefore the quality of dialysis. This study aims to prove that ultrasound-guided AVF cannulation in children will improve the quality of dialysis overall.
Detailed description
The European and American recommandations emphasize that the arteriovenous fistula (AVF) is the first choice vascular access in hemodialysis for both adult and pediatric patients. Indeed, infections and thrombotic complications are lower with an AVF than with a central venous catheter. In addition, the efficiency of dialysis is better in patients with AVF in both pediatric and adult patients.
The pediatric population has its own characteristics. On the one hand, the size of the vessels, in particular in patients weighing less than 20 kilos, complicates the creation of the AVF. On the other hand, the time for AVF maturation in children (corresponding to the time required between the creation of the AVF and its use) is much higher than that of the adult population. These specific anatomical characteristics partly explain the more frequent AVF cannulation difficulties in pediatric patients.
Inadequate dialysis is considered to be a session in which the therapy goals were not achieved. This rate of inadequate dialysis is estimated at 8-10% in children due to vascular access problem, whereas this rate is only 1 to 5% in adults. There is also an increase in side effects related to these pediatric AVF cannulation difficulties (trauma, hematoma, edema following diffusion, etc.) responsible for inadequate dialysis and, in the long term, AVF dysfunction (stenosis, thrombosis).
The preservation of the vascular access by means of new cannulation techniques aimed at limiting trauma is therefore a primary objective in pediatric hemodialysis. The introduction of new cannulation methods as well as the training of nurses/childcare workers in the various puncture techniques would thus make it possible to improve the quality of dialysis sessions, the lifespan of AVFs, to increase the number of puncture sites and reduce the number of punctures per session and the occurrence of complications.
Recently, the ultrasound-guided AVF cannulation technique has shown promising results in adults with regard to the prevention of vascular access complications, the feeling of pain and the obtaining of adequate dialysis.
A recent review points to the need to confirm the benefit of ultrasound-guided cannulation through randomized studies, the current data being promising but needing to be confirmed. To date, no data concerning the benefit of ultrasound-guided cannulation in pediatrics is available in the literature. Our project will therefore be the first research to compare 2 AVF cannulation methods in pediatric hemodialysis. The hypothesis adopted is that the AVF cannulation using ultrasound guidance in children undergoing dialysis will allow an overall improvement of dialysis quality, a reduction of complication occurrence and an improvement of patient comfort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized clinical study comparing two AVF cannulation methodes (conventional vs ultrasound-guided method) in pediatric patients with end-stage renal disease undergoing hemodialysis therapy.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided AVF cannulation method | Experimental | Other: Ultrasound-guided AVF cannulation methodThe AVF cannulation is carried out using ultrasoud guidance |
| Conventional AVF cannulation method | Other | Other: Conventional AVF cannulation methodThe AVF cannulation is carried out by palpation |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pediatric patients ˂ 18 years of age at enrollment
- Patients with end-stage renal disease undergoing hemodialysis therapy
- Patients carrying an arteriovenous fistula created more than 6 weeks before enrollment
- Prior agreement of the patient and their legal representative by signing the parent's informed consent form
- Patients affiliated to social security system
Key exclusion criteria (4 listed)
- Non-matured arteriovenous fistula according to the referring pediatrician
- Patients undergoing dialysis at least partly through a central venous catheter
- Estimated duration of dialysis less than 1 month in the investigation center
- Participation in other intervention research
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-guided AVF cannulation methodFor ultrasound-guided cannulation, the same ultrasound device will be used for all patients (TE5-POC ultrasound MINDRAY® system). The ultrasound device will identify the AVF aspect , the location including the depth (distance from the skin surface) , the vessel diameter and guide the cannulation in real-time. The device will be disinfected between uses and covered with a transparent adhesive film to avoid any direct contact with the patient. Sterile gel will be used for the cannulation. | Other | Ultrasound-guided AVF cannulation method |
| Conventional AVF cannulation methodThe AVF cannulation is carried out by palpation. This technique consists of manually evaluating the position, direction and depth of the fistula in order to determine the puncture site where the 2-dialysis catheters will be inserted. After local asepsis, the AVF is therefore needled at 2 points 5 cm apart. | Other | Conventional AVF cannulation method |
Primary outcome
Compare the rate of inadequate dialysis after ultrasound-guided AVF cannulation vs. conventional cannulation in pediatric patients (<18 years) with end-stage renal disease undergoing hemodialysis therapy.
Time frame: 12 months
Inadequate dialysis is defined by the presence of one of the following parameters: * Blood flow rate (BFR expressed in ml/min corresponding to the volume of blood in milliliters that flows per minute) less than 80% of adequate blood flow corresponding to a flow ≥ 7 ml per kilograms of weight with a maximum of 300 ml/min * Requirement of single-needle dialysis after 3 cannulation failures * Early discontinuation of hemodialysis * Loss of dialysis circuit during the session * Out of range arterial or venous pressure during dialysis requiring a drop in blood flow rate * Purification coefficient defined by Kt/V <1.2: K represents the dialyzer clearance of urea (expressed in milliliters/ min and corresponds to the volume of blood in ml cleared of urea per minute ) // t (in minutes) represents the dialysis time duration // V (in milliliters) represents the volume of distribution of urea, and equals the patient's total body water
7 secondary outcomes
Number of cannulations required for the insertion of the 2 dialysis catheters
Time frame: During procedure
The time required for the insertion of the 2 catheters
Time frame: During procedure
The occurrence of cannulation complications
Time frame: During procedure
The occurrence of dialysis incidents caused by catheters dysfunction
Time frame: During procedure
Patient satisfaction
Time frame: 30 days, 90 days, 180 days and 12 months after enrollment
Patient comfort
Time frame: During the procedure
Patient comfort
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Arteriovenous Fistula Cannulation
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Effect of 4-7-8 Breathing on AV Fistula Needle Pain in Dialysis Patients
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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.
Jean Philippe BOUDET principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided AVF cannulation method and Conventional AVF cannulation method in people with Arteriovenous Fistula Cannulation, run by University Hospital, Montpellier at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the rate of inadequate dialysis after ultrasound-guided AVF cannulation vs. conventional cannulation in pediatric patients (<18 years) with end-stage renal disease undergoing hemodialysis therapy. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.