跳至主要内容
临床试验/CTRI/2020/01/022800
CTRI/2020/01/022800尚未招募不适用

Clinical Validation of Practicability of Capacitive ECG Measurement for Ubiquitous Healthcare

Indian Institute of Technology Madras1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Correlation of Measured cECG data with conventional ECG data for signal quality assessment.

研究概览

简要总结

The objective of the trail is to measure and wirelessly transmit capacitive based electrocardiogram of a patient and validate its practicability in comparison with conventional system in clinical setup. Also to evaluate usability of the system with questionnaire responses. Capacitive plates are used as electrodes to acquire ECG signal from the subjects. Conductive electrodes are capacitively coupled with the skin through an insulator. Copper were chosen as electrode leads due to its good conductivity (6.30×107 S/m) . To make the electrodes 5cm X 8cm with thickness of 0.3mm copper plate were used. Preamplifier board was allocated and soldered with its input lead on one of the plate faces. Output of the pre-amplifier is passed through an instrumentation amplifier of gain 420 followed by high pass and low pass filter of frequency 0.4 to 40 Hz respectively. NodeMCU is used as an IoT platform to receive cECG analog input from acquisition board and transfers the data wirelessly to the web server. Server runs two codes. Once to receive the data transmitted by NodeMCU and the second to write cECG data to a database. Server and the NodeMCU will be connected to the same network through a wifi router. Database is created on the local computer and continuously saves the cECG data as and when received by the server.

The methodology of the trial is as follows:

1.       The experiment protocol and the variables measured will be explained and data collection process will begin only after the participant expresses his/her consent

2.       Measure patient health status by temperature, blood pressure and notes from doctor.

3.       Measure ECG signal from patient through hospital conventional method and our proposed capacitive ECG device

4.       Validate signal quality and device specifications with conventional system

5.       Validate practicality and usability with questionnaire responses from patients, nurses and doctors.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Willingness to participate.

排除标准

  • Any acute or chronic condition that would limit the ability of the patient to participate in the study.
  • Any health conditions or treatment that requires the doctor to limit the patient ability to participate in the study.
  • Refusal of the patient to give informed consent.

结局指标

主要结局

Correlation of Measured cECG data with conventional ECG data for signal quality assessment.

时间窗: 1 year

次要结局

  • Usability evaluation of designed device and interface for continuous cardiac monitoring(3 months)

研究者

申办方类型
Research institution

研究点 (1)

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