The Effect of Vascular Imaging Devices on the Success Rate of Peripheral Vascular Access in Pediatric Patients Undergoing Day-Case and Non-Operating Room Anesthesia Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The time to establish peripheral vascular access
研究概览
简要总结
The study was designed as a prospective, observational study. Pediatric patients under 18 years of age scheduled for peripheral vascular access placement during day-case surgery or non-operating room anesthesia (NORA) will be included. The primary outcomes include time to successful vascular access, number of attempts, and number of interventions (defined as each new skin entry of the needle). These outcomes will be compared between two groups: those who receive vascular access with the aid of a vascular imaging device and those in whom such a device is not used.
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
- 0 Days 至 18 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 0-18 years scheduled for day-case surgery or non-operating room anesthesia (NORA)
- •Patients requiring peripheral vascular access (those with a need for intravenous access)
- •Patients whose parent or legal guardian can provide written informed consent
- •Patients suitable for vascular access using a vascular imaging device
排除标准
- •Patients requiring emergency surgery or urgent intervention
- •Patients whose parent or legal guardian cannot provide informed consent
- •Patients with local extremity problems such as infection, edema, or wound that prevent peripheral vascular access placement
结局指标
主要结局
The time to establish peripheral vascular access
时间窗: pre-intervention/procedure/surgery
The primary outcome measure is the time required to successfully establish peripheral vascular access, defined as the interval from the first needle insertion attempt to the confirmation of intravenous placement (e.g., blood return and/or free flow of saline). This metric will be recorded in seconds and compared between patients who receive vascular imaging assistance and those who do not.
number of attempts
时间窗: pre-intervention/procedure/surgery
The number of attempts refers to the total number of needle insertions required to achieve successful peripheral vascular access, with each attempt defined as a distinct skin puncture. An attempt is counted even if cannulation is not achieved. This outcome will be documented for each patient and compared between the group using vascular imaging devices and the group without such assistance.
次要结局
- number of interventions (each new skin entry of the needle)(pre-intervention/procedure/surgery)
研究者
Sibel Seçkin Pehlivan
Assistant Professor
TC Erciyes University