A Prospective Feasibility Trial of AccuCath 2.25" BC Intravascular Catheter System With Retractable Coiled Tip Guidewire Placed in Difficult Access Patients in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of Catheter Attempts Required to Complete Successful PIV Placement
研究概览
简要总结
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the emergency department.
详细描述
A one arm, prospective feasibility study using the AccuCath 2.25" BC Intravascular Catheter System placed in the upper arm with ultrasound guidance, and the lower arm with and without ultrasound guidance based on clinical assessment. Subjects will be subjected to a maximum of 4 attempts. If unsuccessful by the 4th attempt, alternatives will be considered as per current standard of care.
Currently multiple IV attempts are made in difficult IV access patients without success. Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication. The study will evaluate the feasibility of AccuCath 2.25" BC as a low risk, lower cost alternative for this patient population in lieu of using a midline, peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male or female, age > 18 years old;
- •Capable and willing to give informed consent;
- •English speaking;
- •Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician;
- •Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay;
- •Difficult venous access patient as defined by either 2 failed initial attempts without ultrasound guidance or a history of difficult access plus the inability to directly visualize or palpate a target vein.
排除标准
- •Male or female, < 18 years old;
- •Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
- •Previous venous grafts or surgery at the target vessel access site;
- •Subjects with lymphedema or status-post mastectomy on affected side;
- •Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
结局指标
主要结局
Number of Catheter Attempts Required to Complete Successful PIV Placement
时间窗: At IV insertion attempt, generally from 3-15 minutes
First Attempt Success Rate
时间窗: At initial IV insertion attempt, generally from 3-15 minutes
次要结局
- Dwell Time(Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days))
- Completion of Therapy(During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days)
- Time to Catheter Placement(At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes)
- Complications(During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days)
- Patient Satisfaction(at IV removal, which can be up to a maximum of 29 days)