Benefit of Ultrasound Guidance in Arteriovenous Fistula (AVF) Cannulation in Pediatric Hemodialysis

NCT ID: NCT05556915

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-03
• Study Completion Date: 2024-04-08

Brief 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. 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.

Conditions

Arteriovenous Fistula Cannulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ultrasound-guided AVF cannulation method

The AVF cannulation is carried out using ultrasoud guidance

Group Type: EXPERIMENTAL

Ultrasound-guided AVF cannulation method

Intervention Type: OTHER

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 method

The AVF cannulation is carried out by palpation

Group Type: OTHER

Conventional AVF cannulation method

Intervention Type: OTHER

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.

Interventions

Ultrasound-guided AVF cannulation method

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.

Intervention Type: OTHER

Conventional AVF cannulation method

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Philippe BOUDET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uh Montpellier

Montpellier, Montpellier, France

Countries

France

Other Identifiers

RECHMPL21_0526

Identifier Type: -

Identifier Source: org_study_id