The Efficacy of Near-Infrared Vein Imaging for the Success of Placing Peripheral Venous Catheters in Adults With Difficult Venous Access
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Lahey Clinic
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of Participants With Successful Initial IV Placement
研究概览
简要总结
The objective of this project is to define the effectiveness and therefore the role of NIR vein finders in adult patients with difficult peripheral venous access. The specific objective of the proposed randomized controlled trial is to test the clinical success rate of placing peripheral venous catheters in 'difficult' access patients using traditional peripheral venous catheter placement compared to two established methods utilizing NIR vein imaging. The investigators hypothesize that the capability to successfully place lasting peripheral venous catheters is increased with the adjunct of the imaging technology, reducing the number of failed needle sticks, reducing the number of peripheral venous catheters placed throughout a patient's hospital stay, and reducing the need for more invasive catheters such as PICC lines.
详细描述
The efficacy of NIR vein finders beyond the first line approach, particularly in patients that have failed conventional peripheral venous access methods or in patients that are expected to be a "difficult stick", is not established. Conflicting results have been reported in the pediatric literature regarding the subjective benefit of NIR light devices in patients with perceived difficult peripheral intravenous access. In addition, knowledge about the efficacy of these devices in the adult inpatient setting is mostly unknown. The aim of the present study is to address these knowledge gaps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-pediatric in-hospital patients (≥15 years of age, inpatient and outpatient setting)
- •willing to provide research authorization
- •scheduled and consented to undergo peripheral venous cannulation of one of the upper extremities to be performed by one of the members of the Vascular Access Team
- •determined to be a difficult peripheral venous access defined by one of the following criteria in alignment to the A-DIVA scale to be assessed by one of the members of the Vascular Access Team [8]:
- •failed inspection for more than one visible or palpable suitable vein through conventional methods
- •failed at least one attempt of peripheral venous cannulation through any methods
- •history of difficult peripheral venous access
- •greatest diameter of target vein less than 3mm determined by conventional methods
排除标准
- •clinical contraindication for placement of peripheral venous catheter, including:
- •severe bilateral upper extremity edema
- •severe bilateral upper extremity skin burn
- •severe bilateral upper extremity cellulitis
- •history of bilateral axillary lymphadenectomy
- •known severe cardiovascular or pulmonary compromise demanding minimization of procedure time, such as:
- •severe shock with severe cardiovascular instability
- •active CPR
- •major uncontrolled hemorrhage
- •any condition for which the primary healthcare provider is requesting emergent venous access
- •scheduled PICC or midline catheter placement
- •non-English-speaking patients if an interpreter is not available
- •prisoner and any individual involuntarily confined or detained in a penal institution
- •impaired capacity to make informed medical decisions
结局指标
主要结局
Number of Participants With Successful Initial IV Placement
时间窗: up to 30 minutes
Rate of successful initial placement of a peripheral venous catheter (investigators have up to 30 minutes or ONE attempt before the study allows for change of technique to the preference of the Vascular Access Team member)
次要结局
未报告次要终点