Safety and Efficacy of Midline and Peripherally Inserted Central Catheter for Intravenous Therapy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 293
- 试验地点
- 2
- 主要终点
- % of patients without VAD-related adverse event requiring medical intervention
研究概览
简要总结
The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.
详细描述
Vascular access devices (VADs), including peripherally inserted central venous catheters (PICCs) remain a cornerstone for the delivery of necessary intravenous therapy. PICCs are being selected for venous access more frequently today than ever before.
The advantage of PICC is that it can be used for all intravenous therapy. However, PICC requires the use of fluoroscopy or other type of guidance which add to the cost and time required to insert the catheter. Midline, on the other hand, can be inserted under ultrasound guidance, takes less time to be inserted and cost less than PICC insertion.
Despite lower cost and better accessibility of midline in comparison with PICC for non-vesicant intravenous therapy, there is very little evidence in the literature to suggest that one type of venous access is better than the other.
The primary objective of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.
Results of this trial will allow improving a quality of evidence for using midline instead of PICC for specified indications. If Midline are non-inferior for some indications, they would represent a more accessible and less expensive alternative than PICC insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Required intra venous therapy
- •Expected duration of the venous access: > 6 days and < 30days
排除标准
- •Patient has a contraindication to insertion of either a Midline or a PICC relative to the therapy
- •Patient from other hospitals who come to the CHUM only for the installation of a central line
- •Decreased cognitive ability to care for device at home
- •Preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results)
- •Preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, antithrombin deficiency, lupus anticoagulant)
- •Venous access with multiple lumens required
- •Patients not able to give informed consent
- •Prior participation to this study
- •Patient is enrolled in another investigational study
- •Patients hospitalized in the intensive care unit
- •Patients who are difficult to puncture and require multiple blood samples
结局指标
主要结局
% of patients without VAD-related adverse event requiring medical intervention
时间窗: Until 1 week after VAD retrieval
Infections, Thrombophlebitis, Infiltration, Bleeding, Pain, Death
% of patients whose intended or additional I.V treatments could be completed with the VAD without VAD complications, dysfunctions or limitations (ex: need for central access or for additional peripheral or central lumens/catheters)
时间窗: Until 1 week after VAD retrieval
次要结局
- % of patients who required another VAD to complete the intended or additional iv treatments, either because of VAD complications, dysfunctions or limitations(Until 1 week after VAD retrieval)
- % of patients for whom the end of treatment was the reason for VAD retrieval(Until 1 week after VAD retrieval)
- % of patients who experience VAD-related adverse events requiring medical intervention(Until 1 week after VAD retrieval)
- Time to first VAD-related adverse events(Until 1 week after VAD retrieval)
- % of patient without failed blood sampling attempts through the VAD(Until 1 week after VAD retrieval)
- Number of VAD-related adverse events requiring medical intervention per 1000 catheter/days(Until 1 week after VAD retrieval)
- Duration VAD intervention (Midline or PICC)(Index procedure)
- Number of additional interventions to insert the VAD(Index procedure)