| 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
|
|
|
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
|
|
|
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
|
|
|
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. |