A Data Collection Study to Collect Blood Pressure Data Using the CardiacSense BP Pillow System for Algorithm Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
研究概览
简要总结
Collect raw data from CS BP Pillow System ,CS BP Plate System, IR (Infrared) PPG (Photoplethysmography) sensors and Arterial line (A-line) in volunteers. The data collected in the study will be used for development of the CS BP algorithms.
详细描述
This is a prospective data collection single-site study designed to collect blood pressure (BP) waveforms and estimate BP via the CS BP Pillow System, CS BP Plate System and IR-Pillow in parallel with arterial line (A-line data). The data collected will be used for algorithms development of the CS BP systems.
The study includes a screening phase followed by BP data collection session using the CS Pillow System, CS BP Plate System, IR-Pillows and an A-line. Participants will be recruited by the Investigator according to the study eligibility criteria.
A total of 50 participants who meet eligibility criteria will be enrolled in the study in 3 cohorts: Cohort I and Cohort II will include 20 participants, and Cohort III will include 10 participants.
After informed consent is obtained, demographic information, medical history, current medications use and wrist circumference measurement will be recorded. A modified Allen's test, a lateral difference test and additional assessments will be performed to confirm eligibility criteria. In participants who meet the eligibility criteria, the CS BP study systems will be fitted and an A-line will be inserted into the radial artery. A dynamic response calculation will be performed to confirm the integrity of the inserted line.
After the participant has rested for at least 5 minutes, simultaneous BP recordings using the CS BP Pillow System, CS BP Plate System, IR Pillows and A-line will begin and continue for about 1 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-80 years old.
- •Ability and willingness to sign and understand an informed consent form.
- •The participant has a palpable radial pulse in both wrists.
- •The participant is willing and able to be fitted with the investigational device, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational device and A-line.
- •The participant was fitted with both CS BP Plate System devices (one for each hand) and CardiacSense technician has determined the measurement quality to be sufficient.
排除标准
- •Participant who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the participant or interfere with the data collected.
- •Participant whose body habitus precludes them from wearing the investigational device on their wrists.
- •Female participants who self-reported as pregnant based on a urine pregnancy test, or who are self-reported as trying to get pregnant or who are breastfeeding.
- •Participant whose BMI is greater than
- •Participant with a documented medical history of cardiac arrhythmia.
- •Participant with diagnosed diabetes mellitus.
- •Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
- •Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
- •Participant with pheochromocytoma or primary hyperaldosteronism.
- •Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
- •Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
- •Participant with an infection requiring antibiotics.
- •Participant with peripheral artery disease
- •Participants with compromised circulation, including Raynaud's syndrome.
- •Participant has a fracture, severe trauma, or anatomical deformity involving the wrist intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
- •Participant with moderate to severe valvulopathies.
- •Participant with primary vasculitis.
- •Participant with tremors or otherwise unable to remain still for 1 hour.
- •The left to right arm lateral difference of the average systolic blood pressure values is more than 15 mmHg or the lateral difference of the average diastolic blood pressure values is more than 10 mmHg.
结局指标
主要结局
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
时间窗: day 1, 1 hour
The primary outcome measure is the number of subjects with complete protocol-defined multi-modal physiological signal acquisition. Multi-modal physiological signal acquisition includes simultaneous recording of: (i) photoplethysmography (PPG); ii) single lead electrocardiography (ECG); iii) tonometry signals from the investigational BP Pillow System ; (iv) IR PPG signals (v) continuous invasive arterial blood pressure signals.
次要结局
未报告次要终点