Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
研究概览
简要总结
The purpose of this study is to see if a compression device on the arm where a peripherally inserted central catheter (PICC) line has been inserted can prevent the formation of a blood clot around the PICC line.
详细描述
In a pilot prospective randomized controlled trial, consecutive patients requiring placement of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the SCD (intervention) group or a non SCD (control) group.
Standardized vascular access patency protocols was used in all enrolled patients. All patients had an indwelling 5 French, double lumen PICC unless additional venous access was required by the primary service. Patients randomized to the intervention arm had an SCD placed in the arm with the PICC within 24 hours of PICC placement.
Five to seven days after placement of the PICC, the patients were examined with venous duplex ultrasound of the upper extremity to assess for the presence of venous thrombosis. The patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous thromboembolism, the investigations were performed according to current practice standards. Data collection was be considered complete upon removal of the PICC line.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Subject's age is greater than or equal to 18 years
- •Subject is patient in neuro intensive care unit at time of PICC placement
排除标准
- •Acute trauma to the upper extremity harboring the PICC
- •Current use of prophylactic anticoagulation
- •Inability to fit the SCD on the arm because of arm size
- •Documented previous upper extremity DVT in the arm harboring the PICC line
研究组 & 干预措施
Pneumatic SCD
Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.
干预措施: Pneumatic SCD - VenaFlow System (DJO Global) (Device)
Non-SCD group
Standard care
结局指标
主要结局
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
时间窗: baseline to 14 days post insertion of PICC line
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
次要结局
未报告次要终点
