Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 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 to collect NIBP and invasive aortic pressure data from the clinical setting.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age requirement: 18 and over.
- •Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 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 blood pressure at the aortic root.
- •Able to provide written informed consent.
- •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).
- •Pregnant and lactating women per site standard of care.
- •Subjects with peripheral arterial diseases (causing left/right arm difference)
- •Hemodynamically unstable subjects at the 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 patients that require isolation.
- •PI or designee decision due to subject health conditions
研究组 & 干预措施
Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm)
Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: -Small Adult cuff, or -Adult cuff Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.
干预措施: NIBP Measurement (Device)
Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm)
Subjects with an upper-arm circumference within 31-33 cm, where both Adult (A) and Large Adult (LA) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Adult cuff, or Large Adult cuff Subjects with measurements in non-overlapping A-only or LA-only ranges are assigned the appropriate cuff without randomization and are not included in this arm.
干预措施: NIBP Measurement (Device)
Thigh Cuff (Fallback/Non-Randomized)
Subjects whose arm circumference is either: -Outside the allowable upper-arm range (17-40 cm), or -Eligible but excluded due to fulfillment of upper-arm cuff quotas will undergo thigh circumference measurement. Those with a thigh circumference within 38-50 cm will receive blood pressure measurements using a thigh cuff. Subjects outside the thigh circumference range are excluded prior to any blood pressure measurements.
干预措施: NIBP Measurement (Device)
结局指标
主要结局
Primary Outcome Measure
时间窗: Up to 2 hours after time of enrollment
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
次要结局
未报告次要终点