A Study to Evaluate the Effectiveness of a Novel Device, the RhythmPadBP, in Accurately Detecting Heart Rhythm and Recording Blood Pressure Simultaneously
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Diagnosis of Atrial Fibrillation
研究概览
简要总结
This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.
详细描述
Normally the way a doctor will assess the rhythm of the heart involves asking for an electrocardiogram (ECG) which involves having to remove clothing, and sometimes shaving hair. 10 different leads are attached to stickers that are placed on the chest, and other parts of the body. This is known as a 12-lead ECG and is the standard way that heart-rhythm problems are first investigated. The usual method of measuring blood pressure (BP) involves wrapping a cuff around the arm and inflating it to enough to measure the BP. The reading is then displayed on a monitor. This can sometimes be uncomfortable and is often time consuming, particularly in busy clinical settings.
Recent advances in technology however have given us different ways of gaining some of the same information given by a 12 lead ECG and the standard BP apparatus, using much easier to use devices. One of these devices is the RhythmPadBP system by Cardiocity TM. This is a device where participants can record the underlying heart rhythm and BP readings simply by placing palms of both hands on the device. This device does not require removal of clothing or placing a BP cuff around arm and so the readings can be gained more rapidly and with greater convenience.
Investigators propose to test this device to assess how accurately it recognises the most common cardiac rhythm disturbances, e.g. atrial fibrillation (AF), and also measures the blood pressure. This will help to identify AF and any difference of BP in both arms.
AF is an independent risk factor for stroke and increases the risk of stroke by five-fold. A discrepancy of BP in both arms can be a sign of blood vessel disease and is linked to increased risk of cardiovascular and cerebrovascular disease. If investigators find that this device is correctly recording AF and BP, it may give us another simpler way of diagnosing AF and BP discrepancies on both sides.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater or equal to 18 years
- •Able to consent
- •No known allergies to the metal or any component used in the RhythmPadBP
排除标准
- •Age less than 18 years
- •Not able to consent
- •Allergies to the metal or any component of the RhythmPadBP device
- •Active skin conditions affecting the hands, i.e. burns, infections
- •In-situ cardiac devices i.e. pacemaker or a defibrillator that could interfere with the ECG recording.
结局指标
主要结局
Diagnosis of Atrial Fibrillation
时间窗: 18 months
The diagnosis of Atrial Fibrillation will be achieved through Cardiologist review of p-waves and QRS complexes on both a 1 lead and a 12 lead ECG conducted at the time of study for each participant.
次要结局
- Measurement of BP in both arms with standard BP apparatus Vs RhythmPad BP recordings(18 months)