Study of the Prevalence of Midline Replacements and the Reasons for These Replacements
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 984
- 试验地点
- 1
- 主要终点
- Evaluate the midline replacement rate regardless of the indication, in the various requesting centers
研究概览
简要总结
Venous access management plays a key role in patient care and preserving their venous capital. The so-called "conventional" peripheral venous catheter is the most common venous access device, but it is associated with a high rate of complications, particularly in cases of prolonged use or poor venous capital. Recommendations, such as those from MAGIC or SF2H, advocate their use when the intended duration of use is 5 days or less. For longer periods or in cases of difficult access, so-called "central" devices such as PICC lines or central venous catheters are used, although they present specific risks such as CLASBI or deep vein thrombosis.
In intermediate situations, the midline, a peripheral venous access device, is a relevant alternative, particularly for non-venotoxic intravenous treatments lasting more than 5 days. Although it is theoretically associated with fewer infections and complications than the PICCline, its complication rate and actual duration of use vary widely in the literature.
The MAGIC recommendations suggest using them for periods of 14 days or less. The widespread use of midlines in healthcare facilities, and in particular the creation of vascular access units, has given rise to issues shared between centers, notably the replacement rate of these devices. The study therefore aims to determine the replacement and early removal rates for midlines, the circumstances in which they are replaced, and toassess the relevance of the 28-day limit in the choice of device, in order to improve practices and optimize the practitioner's initial decision.
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
- •Patients over 18 years of age.
- •Patients who have given their consent to participate in the study.
- •Patients treated in a hospital unit authorized to insert midlines, or who have a midline inserted by a professional trained in this procedure, in accordance with the local organization of each center.
- •First insertion for the treatment of a given event with an expected treatment duration of 28 days or less.
- •Patients treated with a midline catheter at least 14 cm in length.
排除标准
- •No coverage by the social security system
- •Failure to insert the midline
- •Patient under guardianship or conservatorship
结局指标
主要结局
Evaluate the midline replacement rate regardless of the indication, in the various requesting centers
时间窗: within 28 days after the initial placement of the midline
The primary endpoint is the cumulative incidence rate of midline replacement over a censored period of 28 days. This period begins on the day of inclusion with the first midline placement, regardless of the indication. Competing events are removal without replacement, regardless of the cause (death, removal at the end of treatment, early removal before the end of treatment without replacement).
次要结局
- Secondary objective 1: To evaluate the early removal rate among patients living with midlines within 28 days of placement.(over a censored period of 28 days)
- Secondary objective 2: Describe the reasons for early removal of midlines.(Withdrawals are analyzed from the day of inclusion and over a censored period of 28 days)
- Secondary objective 3: Describe the lifespan of midlines(This duration includes the number of days between the day of inclusion and the day of device removal over a censored period of 28 days.)
- Secondary objective 4: Describe the replacement rate of midlines among midlines still in place at different time(Days 7, 14, 21 and 28)
- Secondary objective 5: Compare the midline replacement rate between the initial indication of antibiotic therapy and the initial indication of insufficient venous capacity(Replacements taken into account occur over a censored period of 28 days beginning on the day of inclusion)