Effect of Needle Orientation on AVF Cannulation Pain and Post-Removal Haemostasis in Haemodialysis Patients: A Crossover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- AVF cannulation pain as measured by the Numerical Rating Scale NRS AVF cannulation discomfort and bleeding time after removal depending on whether the bevel up or bevel down approach is utilized
研究概览
简要总结
1. Title
Effect of Needle Orientation on AVF Cannulation Pain and Post Removal Haemostasis in Haemodialysis Patients A Crossover Randomized Controlled Trial
2. Background & Rationale
Pain during AVF cannulation and prolonged post needle removal bleeding are common but often overlooked issues in hemodialysis. Evidence is conflicting
KDIGO recommends bevel up insertion.
Recent studies suggest bevel down may reduce pain and bleeding.
However few randomized controlled trials exist. This study will provide comparative evidence between the two routinely used standard cannulation methods.
3. Study Design
Type Investigator initiated single-blinded crossover Randomized Controlled Trial
Setting Hemodialysis Unit Kasturba Hospital Manipal
Study Period March 2025 March 2026
Total Sample
Patients 28
Dialysis staff survey 44
4. Objectives
Primary Objective
To compare pain during AVF cannulation between bevel-up and bevel-down needle orientation using the Numerical Rating Scale .
Secondary Objectives
To compare post needle removal bleeding time between the two orientations.
To assess dialysis staff preferences regarding bevel orientation.
5. Participants
Inclusion Patients
less then18 years
On maintenance hemodialysis for more then 3 months via AVF
Conscious oriented and able to respond
Provide informed consent
Exclusion
AVG or catheter access
Difficult cannulation in last 2 weeks
Unable to communicate
Staff Eligibility Survey
more then 3 months AVF cannulation experience
Working in dialysis unit
Free during data collection time
6. Methods Study Procedure
Eligible patients randomized into bevel up or bevel down group using computer generated sequence.
Visit 1 and 2 Cannulation per assigned orientation.
Visit 3 and 4 Crossover to the alternate orientation.
Pain assessed during each cannulation using NRS.
Bleeding time measured after needle removal.
Complications hematoma infiltration documented.
Staff complete an anonymized questionnaire assessing bevel orientation preference.
Note Both cannulation methods are part of routine care; no additional risk is introduced.
7. Outcomes
Primary Outcome
Pain score during cannulation NRS
Secondary Outcomes
Post needle removal bleeding time
Staff preference on bevel orientation
8. Statistical Analysis
Descriptive statistics for demographic variables.
Repeated Measures ANOVA or Friedman test for comparing pain and bleeding time.
Shapiro Wilk test for normality.
9. Risks & Benefits
Risks
No additional risk as both bevel up and bevel down are standard clinical methods.
Benefits
Potential to identify the technique offering least pain and best haemostasis improving patient comfort and clinical practice.
10. Ethics
IEC approval obtained.
Written informed consent mandatory.
Confidentiality and voluntary participation ensured.
Any complications managed as per hospital protocol at no additional cost to participants.
11. Funding
No external funding. No budget requirement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 and older who are receiving continuous haemodialysis for more than three months via an arteriovenous fistula.
- •Patients who are conscious oriented and able to understand and respond to the questionnaire.
- •Patients willing to provide informed consent.
排除标准
- •Haemodialysis patients with AVG as their permanent vascular access and patients with temporary access catheter
- •Difficulty in AVF cannulation in the last two weeks of dialysis more than one attempt at cannulation needed for at least two sessions 3.Diminished mental capacity or not able to communicate.
结局指标
主要结局
AVF cannulation pain as measured by the Numerical Rating Scale NRS AVF cannulation discomfort and bleeding time after removal depending on whether the bevel up or bevel down approach is utilized
时间窗: baseline
次要结局
未报告次要终点
研究者
Shashank R Nayak
Manipal College of Health Professions (MCHP)