FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/01/022800 [Registered on: 16/01/2020] Trial Registered Prospectively
Last Modified On: 09/01/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Validation of contactless ECG acquisition system 
Scientific Title of Study   Clinical Validation of Practicability of Capacitive ECG Measurement for Ubiquitous Healthcare 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Venkatesh Balasubramanian 
Designation  Professor 
Affiliation  Indian Institute of Technology Madras 
Address  RBG Labs, Department of Engineering Design, IIT Madras

Chennai
TAMIL NADU
600036
India 
Phone    
Fax    
Email  chanakya@iitm.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Venkatesh Balasubramanian 
Designation  Professor 
Affiliation  Indian Institute of Technology Madras 
Address  RBG Labs, Department of Engineering Design, IIT Madras

Chennai
TAMIL NADU
600036
India 
Phone    
Fax    
Email  chanakya@iitm.ac.in  
 
Details of Contact Person
Public Query
 
Name  Venkatesh Balasubramanian 
Designation  Professor 
Affiliation  Indian Institute of Technology Madras 
Address  RBG Labs, Department of Engineering Design, IIT Madras

Chennai
TAMIL NADU
600036
India 
Phone    
Fax    
Email  chanakya@iitm.ac.in  
 
Source of Monetary or Material Support  
Indian Institute of Technology Madras (IIT Madras), Adyar, Chennai - 6000036 
 
Primary Sponsor  
Name  Indian Institute of Technology Madras  
Address  Indian Institute of Technology Madras (IIT Madras), Adyar, Chennai - 6000036 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rebecca Punithavalli  Institute Hospital  Indian Institute of Technology Madras, Near Kendra Vidyalaya School, 1st Cross Road, IITM Campus, Chennai, Tamil Nadu 600036
Chennai
TAMIL NADU 
04422578330

cmo@iitm.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - IITM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteers with no specific illness willing to participate in the study will be participating.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Willingness to participate 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Correlation of Measured cECG data with conventional ECG data for signal quality assessment.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Usability evaluation of designed device and interface for continuous cardiac monitoring  3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.

 
Close