A Prospective, Multi-center, Open-label, Randomized, Controlled Non-inferiority Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter Versus Traditional PIV in the Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 4
- 主要终点
- Acceptance of the overall performance of the IV catheter system
研究概览
简要总结
This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.
详细描述
This is a prospective, multi-center, open-label, randomized, controlled, non-inferiority clinical trial designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter compared to PIVC in the Chinese population in order to support the product's registration in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •≥18 years of age;
- •Inpatient with a need for intravenous infusion for an expected period of more than 4 days but no more than 28 days;
- •The veins in the upper limbs is suitable for puncture and catheterization of both the investigational device and the control device;
- •Willing to provide written Informed Consent and complete the study per the protocol.
排除标准
- •Coagulation disorder or active bleeding;
- •Skin injury, infection, or dermatosis at the site to be punctured;
- •History of radiotherapy, thrombosis, or vascular surgery; arteriovenous fistula or phlebitis history at the area and/or vein to be catheterized;
- •History of mental illness;
- •End stage renal disease requires vein protection;
- •Conditions with decreased venous flow in the extremity, such as lymphedema of the arm, etc.;
- •Infusions of vesicant or irritant drugs, hyperosmotic infusate (the osmotic pressure >900mOsm/L in this study), parenteral nutrition, etc., which are not suitable for peripheral intravenous infusion (If other appropriate venous access is established for the aforementioned infusates, the patient may be enrolled).
- •The evaluation of the upper limb veins is Grade II, the evaluation grade is as following:
- •0 Veins are obviously bulged on the skin surface. The veins are touchable, thick, straight, soft, elastic and fixed.
- •I Veins are relatively full and faintly touchable. The veins are less elastic or slide easily.
- •II Veins are not full or collapsed and untouchable. The veins are hard or sliding. Phlebitis.
- •Self-reported being pregnant or lactating;
- •Other conditions that the investigator considers improper for the study;
- •Participating in another study or already enrolled.
研究组 & 干预措施
Powerme midline catheter
Powerme midline catheter
干预措施: catheter placement (Device)
peripheral intravenous catheter
BD Pegusas peripheral intravenous catheter
干预措施: catheter placement (Device)
结局指标
主要结局
Acceptance of the overall performance of the IV catheter system
时间窗: up to 28 days
After the placement of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 1. Can the IV catheter system vent the air properly; 2. Can the IV catheter system be inserted and be placed in the blood vessel; 3. Can the needle tube be withdrawn from the septum; After the removal of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 4. Can the IV catheter system be removed properly; 5. There is no leakage during the application of the IV catheter system (including the processes of venting, infusion, flushing and sealing, and indwelling).
次要结局
- Incidence of adverse events(up to 28 days)
- Incidence of phlebitis(up to 28 days)
- Success rate of the first insertion of the catheter(First day, during catheter insertion)
- Indwelling time(up to 28 days)
- Rate of good performance of the pinch clamp(up to 28 days)
- Incidence of catheter blockage(up to 28 days)
- Incidence of accidental dislodgement(up to 28 days)
- Incidence of serious adverse events(up to 28 days)