The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection Compared To Standard Gel-Electrode-Based ECG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- From the ECG record collect the T Wave width (sec.) and the amplitude (mV).
研究概览
简要总结
The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG.
The electrodes are dry, textile ECG electrodes. The garment is designed to position the electrodes in the appropriate anatomical locations, without any special guidance. The dry electrodes are made from unique yarns with silver embedded into the garment using a proprietary technique developed by HealthWatch (HW)that obviates the need for skin preparation or the application of fluids. The garment can be connected to any standard ECG device available in the hospitals.
The purpose of this study is to evaluate the safety and effectiveness of the Master Caution Garment for continuous monitoring of ECG signal compared to standard gel electrodes.
The following endpoints will be evaluated in subjects participating in the study:
Primary:
Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes using standard ECG devices.
Secondary:
Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes when event is detected by the ECG devices.
详细描述
Part A - ECG in Rest
- In the beginning of the study, the following parameters will be measured and documented in the CRF: blood pressure, body temperature, respiratory rate and oxygen saturation in the blood.
- The patient will be dressed with the Master Caution Garment and connected to a 12 lead ECG device. The procedure takes 5 minutes including data printing.
- A twelve lead ECG with gel electrodes will be done and data printed. The procedure takes 5 minutes. The patient will stay connected to the monitor for the following hour.
- After an hour the data from the gel electrodes will be printed again.
- The patient will be dressed again with the Master Caution Garment and connected to a 12 lead ECG device. The procedure takes 5 minutes including data printing.
- The following parameters will be compared between the gel ECG and the Garment ECG:
- Heart Rate (HR)
- P wave width and amplitude
- QRS complex width and amplitude
- T wave width and amplitude
- RR interval
- PR interval
- QT interval
Part B - ECG in motion
- In the beginning of the study, the following parameters will be measured : blood pressure, body temperature, respiratory rate and oxygen saturation in the blood.
- Four (4) gel electrodes will be placed on the patient on the following places - Left Arm (LA), Right Arm (RA), Left Leg (LL) and Right Leg (RL).
- The patient will be dressed with the Master Caution Garment (MCG)on the 4 gel electrodes that were already placed.
- The same 4 electrodes in the garment LA, RA, LL and RL will be connected to a standard of care ECG device.
- The 4 gel electrodes will be connected to a standard of care ECG device.
- The ECG devices will be recording the ECG signal from the two sets of electrodes for 24 hours.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years.
- •Suspected for arrhythmia or have evidence of arrhythmia disorder.
- •Needs continuous, in-hospital ECG monitoring.
- •Ability to give informed consent.
排除标准
- •Patients with known allergy to silver.
- •Patients with recent trauma to chest wall.
- •Pregnant or lactating woman.
- •Patients with chest deformity precluding placement of the garment.
- •Patients participating in another ongoing trial.
研究组 & 干预措施
Master Caution Garment
each patient will be connected simultaneously with two devices:
- ECG gel electrodes
- Master Caution Garment textile electrodes The two devices will be connected to hospital ECG telemetry.
干预措施: Master Caution Garment (Device)
Master Caution Garment
each patient will be connected simultaneously with two devices:
- ECG gel electrodes
- Master Caution Garment textile electrodes The two devices will be connected to hospital ECG telemetry.
干预措施: ECG gel electrodes (Device)
结局指标
主要结局
From the ECG record collect the T Wave width (sec.) and the amplitude (mV).
时间窗: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
From the ECG record collect the Heart Rate HR.
时间窗: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
From the ECG record collect the PR Interval width (sec.).
时间窗: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
From the ECG record collect the P Wave width (sec.) and the amplitude (mV).
时间窗: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
From the ECG record collect the QRS Complex width (sec.) and the amplitude (mV).
时间窗: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
From the ECG record collect the RR Interval width (sec.).
时间窗: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
From the ECG record collect the QT Interval width (sec.).
时间窗: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
次要结局
未报告次要终点