Non-Invasive Blood Pressure Accuracy Study for Neonate and Pediatric Subject Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.
详细描述
The purpose of the study is to collect clinical data for validation of the accuracy of non-invasive blood pressure (NIBP) measurement algorithms on the Non-invasive Blood Pressure (NIBP) Standard Parameter Module (SPM) per IEC 80601-2-30:2018, Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standard, section 201.106. In addition, the study will be conducted per ISO 81060-2:2018+AMD2:2024 Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age requirement: 0 to < 18 years.
- •For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR
- •For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation.
- •Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
- •Have an arterial line as a standard of care, which measures invasive blood pressure.
- •Expected to remain in the unit for the duration of the study procedure.
排除标准
- •Have previously participated in this study (no subject may participate more than once).
- •Subjects with peripheral arterial diseases (causing left/right arm difference).
- •Hemodynamically unstable subjects Subjects with complications on vasoactive agents at discretion of the Investigator.
- •Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
- •Are suffering from infection(s) or immunocompromised subjects that require isolation.
- •For adolescents of child-bearing potential, who are currently pregnant, suspected to be pregnant, or are currently lactating.
- •PI, designee or caring physician decision due to subject health conditions
结局指标
主要结局
Primary Outcome Measure
时间窗: Up to 12 hours from time of study procedure start
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
次要结局
未报告次要终点