Appropriateness of Replacing Fluoroscopic Guidance by ECG Guidance in PICC Insertion, RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Tip to CAJ (Cavo-atrial junction)
研究概览
简要总结
The aim of this study is to compare two techniques of placing a peripherally inserted central venous catheter (PICC). The first technique, uses ECG based electromagnetic guidance (ECG-EM). The second (reference technique), is guided by X-ray (fluoroscopy).
详细描述
The method of placement under fluoroscopic control (FX) is considered as the reference technique. This is often criticized for disadvantages such as costs, logistical problems and relative ionizing radiation. Despite this, it is still advised by 75% of PICC providers.
Appeared about ten years ago, a per procedural guiding technique with intracavitary ECG tracking (ECG-EM) presents a better technical success (precision and specificity) than the blind technique, but there is still a lack in comparing this technique to the FX technique.
This prospective randomized controlled study is designed to compare the PICC insertion using ECG-EM guidance to fluoroscopic (FX) guidance in order to define whether a replacement of the FX technique by ECG-EM is appropriate in terms of the final catheter tip position of the PICC as well as length of the outgoing catheter at the entry point.
All included patients gave their written consent and the study is approved by EC.
Participation is open to all adults referred to the radiology department of the CHUV for insertion of a PICC (monocentric).
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 (Informed Consent Form)
- •Adult > 18 years
- •Referred to the interventional radiology department for PICC insertion
排除标准
- •Pregnant women
- •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
结局指标
主要结局
Tip to CAJ (Cavo-atrial junction)
时间窗: Up to 1 hour, after the procedure
At the end of intervention tip position is measured on chest fluoroscopic X-ray. Absolute distance from tip to CAJ is measured on the image. This will reflect proportions of optimal tip positions depending on guidance technology. Rationale is that optimal position is mandatory for adequate functioning of PICC as malpositions may result on cardiac rhythm disorders, thrombosis or premature PICC occlusion.
次要结局
- Length of the outgoing catheter(Up to 1 hour, after the procedure)
- Inter-observer and intra-observer variance(Through study completion, an average of 9 month)
研究者
Salah D. Qanadli
Prof. MD PhD
University of Lausanne