ModPG3 Adult and Pediatric AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
研究概览
简要总结
Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.
Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases.
SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation.
The purpose of this study is to test the algorithms contained in the ModPG3 on Adult and Pediatric subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 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
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.
- •Subject must be willing and able to comply with the study procedures.
- •Subject must be ≥ 3 years of age
- •Subjects that are between 7 and 17 years of age must provide assent to participate in the study.
- •Subject or legally authorized representative must be able to read, write, speak in English, French or Italian.
- •Subjects must have an arm circumference in the range of 12-55 cm and fit into the usable range for the reference cuffs.
- •Subject must be able to have blood pressures measured on the Left arm.
排除标准
- •Lack of Informed consent.
- •Subjects with deformities or abnormalities that may prevent proper application of the device under test.
- •Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
- •Subjects with known heart dysrhythmias.
- •The subject is in acute distress, i.e., severe pain or, severe emotional distress or agitation that would inhibit him/her from participating in the study.
- •The subject has any known contraindication to blood pressure measurement.
- •Subjects with compromised circulation or peripheral vascular disease.
- •Subjects with clotting disorders or taking prescribed blood thinners.
- •Subjects that cannot tolerate sitting for up to 1 hour.
- •Subject with a blood pressure demographic that has already been filled.
- •Subjects with a severe contact allergy to cuff material.
- •Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of noninvasive blood pressure cuff.
- •Subjects whose arm circumference does not fall within the unusable range for the reference cuffs.
- •Subjects with no audible K5 sound.
- •Subject is pregnant and/or breastfeeding.
研究组 & 干预措施
Blood pressure readings
The study will be conducted in 2 parts.
- Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm enabled.
- Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm enabled.
The study requires three observers. The first two observers take auscultatory readings that are averaged to use as reference blood pressures. The third observer operates the ModPG3 investigational device and records the readings for that device.
The two clinicians taking reference readings will be blinded to each other's readings and to the investigational device readings.
干预措施: ModPG3 Investigational Device (Device)
Blood pressure readings
The study will be conducted in 2 parts.
- Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm enabled.
- Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm enabled.
The study requires three observers. The first two observers take auscultatory readings that are averaged to use as reference blood pressures. The third observer operates the ModPG3 investigational device and records the readings for that device.
The two clinicians taking reference readings will be blinded to each other's readings and to the investigational device readings.
干预措施: Auscultatory Equipment (Device)
结局指标
主要结局
Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
时间窗: Day 1 (up to 1 hour)
BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
次要结局
未报告次要终点