Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Distance from catheter tip to cavo-atrial junction (CAJ)
研究概览
简要总结
The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.
详细描述
One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment
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
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Adult > 18 years
- •Referred to the interventional radiology department for PICC insertion
排除标准
- •Known or suspected non-compliance
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)
- •Enrolled in conflicting research study
- •Weight> 150 kg, technical limit for the fluoroscopy table
- •Impossibility of obtaining informed consent
- •Refusal to be informed in the event of a chance discovery
研究组 & 干预措施
Saline ECG with Pilot Tip Location System
PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water
干预措施: LifeCath-CT PICC easy™ (Vygon) (Device)
Guidewire ECG with Sherlock Tip Confirmation System
PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire
干预措施: PowerPICC-SOLO® (C.R. Bard) (Device)
结局指标
主要结局
Distance from catheter tip to cavo-atrial junction (CAJ)
时间窗: At the end of intervention
At the end of intervention tip position is measured on chest fluoroscopic X-ray. Absolute distance in centimeters from tip to CAJ is measured on the image
次要结局
- Haemostasis time(At the end of intervention)
- Length of the outgoing catheter(At the end of intervention)
研究者
Salah D. Qanadli, MD, PhD
Professor MD PhD
University of Lausanne