iPhone App Compared to Standard RR-measurement - iPARR Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,019
- 试验地点
- 2
- 主要终点
- Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg)
研究概览
简要总结
In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S) to determine systolic blood pressure (RR) and compare it to conventional oscillometric measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person. Primary parameter will be the absolute difference (Delta) between the correlating blood pressure measurements in mmHg.
详细描述
Participants will be asked for consent at the University Hospital Basel at random based on availability. Recruitment is not limited to patients. After consenting patients will accompanied to a RR-measurement unit, positioned in a chair and kept at rest for 4 minutes. Then 7 blood pressure measurements at the same arm will be performed (Cuff/iPhone/Cuff/iPhone/Cuff/iPhone/Cuff). The Cuff measurement results will be documented in the source documents (mmHg) and transferred to a trial database. The iPhone data will be transferred with patient ID to "Preventicus" for calculation of the systolic blood pressure values (mmHg) based on the pulse waves recorded by transillumination of the index fingers of the participants. "Preventicus" will have NO access to the Cuff-measurement data. Then this data will be retransferred to the trial site and merged with help of the patient ID. Absolute and relative differences of the measured (Omron) and calculated (iPhone) systolic blood pressure values (mmHg) for will be calculated and published.
A subgroup of 40 participants will be evaluated in a highly standardized fashion according the ESH (European Society Hypertension) guidelines for validation studies. These data will then be published separately for validation purposes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to give informed consent
- •in Sinus rhythm
- •no anatomical limitation to take blood pressure
排除标准
- •Atrial fibrillation
- •Dialysis shunt
结局指标
主要结局
Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg)
时间窗: 1 day
In each participant seven repetitive blood pressure measurements will be performed. Starting with a conventional cuff measurement followed by an iPhone measurement, followed by a conventional cuff measurement and so on. Then the absolute difference between each pair of successive measurements will be calculated. These differences will then be averaged and documented as primary result.
次要结局
- Relative difference between oscillometric blood pressure measurement and iPhone based blood pressure measurement(1 day)
- Percent of invalid measurements(1 day)
- Comparison of primary outcome in the subgroup of patients with atherosclerosis compared to the participants without arteriosclerosis.(1 day)
研究者
Jens Eckstein
PD Dr. med, Leitender Arzt
University Hospital, Basel, Switzerland