May Intravascular Electrocardiography (IVECG) During Insertion of Peripheral Inserted Central-venous Catheters (PICC-line) Replace Chest X-ray?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PICC-tip placement examined by chest X-ray
研究概览
简要总结
This study will provide further knowledge concerning the use of electrocardiography (ECG) signals for verification of peripherally inserted central catheter (PICC) tip placement. Furthermore, it will be investigating whether use of Intravascular ECG (IVECG) for this verification is just as good as or even better than the current standard method with chest X-ray. This can help promote a method that involves less radiation and increased safety for patients, while at the same time saving resources. If use of ECG signals from the PICC tip is an equally exact method for verification of correct PICC tip placement as chest X-ray verification, the IVECG could replace chest X-ray control.
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
- Single (Outcomes Assessor)
盲法说明
The radiologist is masked/blinded in this clinical trial.
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
- •In need for PICC
- •>18 years old
- •Competent to give consent
排除标准
- •Not visible p-wave on surface ECG (electrocardiograph)
- •Patients with known Atrial fibrillation or atrial flutter
- •Implanted pacemaker (PM) and/or implanted Implantable Cardioverter Defibrillator (ICD)
- •Not signed written informed consent
研究组 & 干预措施
Standard
Standard method, PICC tip placement confirmed by postoperative chest X-ray .
干预措施: Chest X-ray (Device)
IVECG and chest X-ray
The patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray.
干预措施: IVECG (Device)
IVECG and chest X-ray
The patients in this group will be examined with perioperative IVECG for PICC tip placement, as well as standard postoperative chest X-ray.
干预措施: Chest X-ray (Device)
结局指标
主要结局
PICC-tip placement examined by chest X-ray
时间窗: 45 minutes
Placement of PICC-tip examined by chest X-ray both in observation group and in control group. A radiologist will examine the distance from the tracheal carina to the PICC-tip, and this measure will be registered in mm in both groups. Further the radiologist will be answering a questionnaire regarding "correct placement of PICC-tip", YES or NO, which is defined as in the lower 1/3 of the superior vena cava or at the cavo atrial junction. Last also the anesthesiologist will be answering following question: Is the PICC-tip placement acceptable? YES or NO
次要结局
未报告次要终点