Intérêt De L'échoguidage Dans Les Ponctions De Fistule Artério-veineuse En Hémodialyse Pédiatrique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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
次要结局
- The time required for the insertion of the 2 catheters(During procedure)
- Number of cannulations required for the insertion of the 2 dialysis catheters(During procedure)
- Patient satisfaction(30 days, 90 days, 180 days and 12 months after enrollment)
- The occurrence of cannulation complications(During procedure)
- The occurrence of dialysis incidents caused by catheters dysfunction(During procedure)
- Patient comfort(During the procedure)