Optical Detection of Intravenous Infiltration:A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ivWatch, LLC
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Time Infiltration Detected by Nurse
研究概览
简要总结
This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent and/or assent
- •Newborn to 17 years of age
- •Weight > 2.5 kg
排除标准
- •Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
- •Severe scarring of tissue (excessive IV use)
- •Tattoo in area of PIV site
- •IV site located in antecubital fossa
结局指标
主要结局
Time Infiltration Detected by Nurse
时间窗: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Infiltration Sensitivity
时间窗: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Notification Rate of ivWatch Device
时间窗: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.
次要结局
未报告次要终点