Prospective Observational Study on Picclines' Complications at Brest Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Complication in patient with piccline
研究概览
简要总结
This is a prospective monocentric study of PICC Line complications use in 5 medical and one surgical units of Brest Medical University Hospital.
To evaluate the incidence of the following complications: infections, thromboses, mechanical and hemorrhagic, at month 3 post-intervention.
Also evaluating:
- the management of these PICC Line related complications,
- risk factors for such complications,
- and the mortality-related outcomes.
详细描述
All eligible patients fulfilling the inclusion criteria, after PICC Line placement, will receive oral and written patient information describing the study deployment and follow-up. Patients will be followed up until PICC Line removal if it occurs during the first 3 months after placement or until death if it occurs during the first 3 months, or during 3 months in the absence of complications.
- Infectious complications are described in accordance with IDSA 2009 guidelines and include bloodstream infection, endocarditis, local infection and septic thrombophlebitis.
- Thrombotic complications are defined as symptomatic, deep, or superficial venous thrombosis, confirmed by Ultrasound and Echo-Doppler or asymptomatic venous thrombosis diagnosed fortuitously.
- Mechanical complications are defined as impairments related to PICC Line device: occlusion, rupture, accidental removal.
- Hemorrhagic complications are defined as hematoma or bleedings of puncture site.
In the event of PICC Line-related complications, patient will be followed up for an additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration of 6 months.
Each week during the first month, then once monthly during the follow-up (i.e. W1, W2, W3, W4, M2, M3, +/- M4, M5, M6), all patients data related to the PICC Line retention or removal, use and all its related complications will be collected.
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
- •Patient > 18 yo
- •Patients > 18 yo hospitalized in internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016 and March 9, 2017
排除标准
- •Patients hospitalized in other units than those cited above
- •Patients verbal refusal to participate in the study
结局指标
主要结局
Complication in patient with piccline
时间窗: 3 month
次要结局
未报告次要终点
