A Prospective, Multi-center, Randomized, Open Label, Controlled Trial of BD Pre-filled Flush Syringes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 6
- 主要终点
- the Overall Performance for Flushing and / or Locking the Catheters.
研究概览
简要总结
This study is to compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by Suzhou Becton Dickinson Medical Devices Co., Ltd.) for locking and flushing the end of catheter line in Chinese popluation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >or equal to 18, no limitation on gender;
- •Hospitalized patients;
- •Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC));
- •Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy;
- •Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form.
排除标准
- •Patient reports pregnancy or lactation (self-report);
- •Subjects who are known to have blockage or recanalization of vascular access prior to this trial.
- •Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial.
- •Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment;
- •Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.
结局指标
主要结局
the Overall Performance for Flushing and / or Locking the Catheters.
时间窗: one hour after treatment
Evaluation method: Overall performance is assessed by a Nurse, who need to answer the following questions: 1. Can air in the BD Pre-filled Flush Syringes be expelled successfully? 2. Can BD Pre-filled Flush Syringes be connected to the catheter smoothly? 3. Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? 4. Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? 5. Any leakage observed at any part of the Flush syringe at any time during the usage? Overall performance for flushing and/or locking the catheter is only considered as "success" if: Question 1 to 4 answered with "YES", and question 5 answered with "NO".
次要结局
- Device Ease of Use(one hour after treatment)