NCT06172829撤回不适用
Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line Against Invasive Intra-arterial Reference According to the ANSI/AAMI/ISO 810602-2019 Protocol for Neonates, Infants, Children
SunTech Medical1 个研究点 分布在 1 个国家开始时间: 2023年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The blood pressure measurement
研究概览
简要总结
Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Data collected from the Advantage MX module will be compared to the reference data from the intra-arterial line.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 3 subjects shall be < 1,000g in weight.
- •At least 3 subjects shall be 1,000g to 2,000g in weight.
- •At least 3 subjects shall be >2,000g
- •At least 3 subjects shall be ≥ 29 days and < 1 year of age.
- •At least 3 subjects shall be ≥ 1 year and < 3 years of age.
排除标准
- •Subjects who study personnel determine invasive blood pressure measurements will be unreliable
- •Patients found to have a-fib, irregular heart rhythm, dysrhythmias, bigeminy, trigeminy, and isolated premature ventricular beats (VPBs) during the enrollment process are to be ineligibile to participate in the study
- •Patients who are prescribed anti-coagulation medication during the enrollment process or begin anti-coagulation medication after enrollment are ineligible to participate in the study.
- •Exclusions can also occur post-data review based on exclusion criteria according to ANSI/AAMI/ISO 81060-2:2019
结局指标
主要结局
The blood pressure measurement
时间窗: approximately 1 hour
collected from the Advantage MX module matches the intra-arterial line data
次要结局
未报告次要终点
研究者
研究点 (1)
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