Early Feasibility Data Collection Using ClearSight on Children Less Than Two Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proper cuff fit
研究概览
简要总结
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.
详细描述
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old
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
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age < 2 years
- •Availability of a standard blood pressure measurement as part of standard of care
排除标准
- •Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
- •Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
- •Known sensitivities to system materials
- •Broken or open skin located at the site of the finger cuff
- •Proven left-right difference in blood pressure
- •Cardiac problems that can cause a difference in blood pressure between the two arms, including aortic coarctation
- •Extreme contraction of the smooth muscles in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
结局指标
主要结局
Proper cuff fit
时间窗: 30 minutes of monitoring with study devices during scheduled surgery procedure
The cuff fits properly on the participant's finger in at least 90% of total number of participants. Proper Fit is defined as complete overlap of the hook and loop areas attached to the cuff and the securement flap.
Cuff remains properly fitted for the duration of the study measurement
时间窗: 30 minutes of monitoring with study devices during scheduled surgery procedure
The cuff remains properly fitted for the duration of the study measurement for at least 90% of total number of participants.
Measurement with monitor started without errors
时间窗: 30 minutes of monitoring with study devices during scheduled surgery procedure
A measurement can be started without the monitor producing errors and a blood pressure waveform is measured in at least 60% of the attempts, unless the monitor is warning for vaso-constriction.
Measurement stability within 10 mins
时间窗: 30 minutes of monitoring with study devices during scheduled surgery procedure
The automatic physiological calibration (Physiocal) stabilizes to intervals ≥ 30 beats within 10 minutes in at least 60% of the attempts, indicating measurement stability unless the monitor is warning for vaso-constriction.
Early feasibility accuracy
时间窗: 30 minutes of monitoring with study devices during scheduled surgery procedure
For systolic blood pressure and diastolic blood pressure the mean value of the errors of all individual paired determinations of the ClearSight versus reference blood pressure shall be within or equal to ±5 mmHg, with a standard deviation, no greater than 8 mmHg.
次要结局
未报告次要终点