An Observational, Prospective, Single-center Study of Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 1
- 主要终点
- Efficacy of PICC placement using the Sherlock 3CG
研究概览
简要总结
This is a prospective, single center, observational study. Patients who require a Peripheral Inserted Central Catheters (PICC) will constitute the study population.
The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the total placement of PICC and confirmation of tip of PICC placement and if this method can be conducted safely and efficiently.
Patients will be included during a 6-month period as well as they are ambulatory or hospitalized. The patient's routine care will not be modified and only PICC will be assessed in the present study.
PICC placement will be performed using the Site Rite guidance and tip position will be confirmed using the Sherlock 3CG.
The procedure is the same as the routine habits of the operator (nurse or anesthesiologist); the vascular access team already uses the previous device for CVC placement.
Patients won't be followed up in the study.
详细描述
Our current Central Venous Catheter placement protocol for PICC includes the resort to UltraSonography (US) and requires fluoroscopy and plain radiographies throughout the PICC insertion and until the confirmation of best placement.
This verification is mandatory to avoid the risks, delays and costs of repositioning the tip, but obtaining a fluoroscopy and plain radiographies in operating rooms can be time consuming and exposes the patient, nurses and physicians to radiations.
The use of endocavitary electrocardiogram for tip position confirmation has been developed since 1985 and is now recognized as an alternative method. It has been recognized as the best technique in other indications, such as hemodialysis. It helps to position PICC tip in proximity to the cavoatrial junction. In Europe, Italian and German teams already use this new method.
A new ultrasound machine offering external sensors and Endocavitary ECG guide is now available (Site Rite and Sherlock 3CG - Tip Confirmation System), which allows the installation and proper placement in the same operation. This Sherlock 3CG TCS has already been approved by the Food and Drug Administration in the US and is indicated for PICC tip placement confirmation in adult patients.
This new ECG guidance method will allow the PICC insertion without any radiation in the operating room.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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-old patient or older,
- •Patient requiring PICC placement in the vascular access unit,
- •Patient able to read and understand the French language,
- •Patient affiliated with a social security system.
排除标准
- •Any contraindication to PICC insertion,
- •Patient unable to lie in the supine position
- •Patient with a Body Mass Index > 40
- •Any medical condition that could change the normal presentation of the P-wave such as arrhythmia, atrial flutter, pace maker with permanent stimulation...
结局指标
主要结局
Efficacy of PICC placement using the Sherlock 3CG
时间窗: During the procedure (Day 0)
Success rate of PICC placement (no need to use radiation or fluoroscopy before the end of the procedure)
次要结局
- Assess the unique punction rate(During the procedure (Day 0))
- Assess pain(During the procedure (Day 0))
- Assess acute complications rate(During the procedure (Day 0))
- Assess the number of punctures in brachial site(During the procedure (Day 0))
- Assess the percentage of patients with good placement on the X-Ray(During the procedure (Day 0))
- Assess the number of repositions after procedure closed(During the procedure (Day 0))
- Assess the percentage of patients requiring fluoroscopy(During the procedure (Day 0))
- Assess the final radiation rate(During the procedure (Day 0))