NICU-TECH RM9L-RS Probe ME Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Participants That Fulfilled All Study Procedures.
研究概览
简要总结
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself. An observational study to assess the the clinicians perception of the ultrasound image quality as a tool to detect catheters in vessels.
详细描述
The intent of the study is to confirm the maximum penetration of the NICU-Tech RM9L-RS probe. The investigators collected images on patients with PIV (Peripheral Intra Venous)/PAC (Peripheral Arterial Catheter) and central line catheters. The investigators collected images of deep vessel structures for offline processing to improve NICU-Tech algorithms for vessel segmentation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 23 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates that are 23 gestational weeks at birth (and greater than 500 grams) to a 6 month old born infant at term (maximum weight 7 kg) who already have one or more lines placed (PIV/PAC/UVC/UACs/PICC) as part of their medical care. NO INFANT WILL HAVE A LINE PLACE FOR THE PURPOSE OF THIS STUDY
排除标准
- •Neonates that are less than 23 gestational weeks at birth
- •Neonates that are 23 gestational weeks at birth but are less than 500 grams in weight
- •Patients weighing more than 7 kg.-Patients older than 6 months
结局指标
主要结局
Participants That Fulfilled All Study Procedures.
时间窗: 1 day (day of procedure)
Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place.
Vessel Penetration of NICU-Tech RM9L-RS Probe
时间窗: 1 day (day of procedure)
The algorithmic depth of vessel penetration will be collected.
次要结局
未报告次要终点