| CTRI Number |
CTRI/2022/08/044905 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Non-contact testing of vitals for the patients visiting Kasturba Hospital- Manipal |
|
Scientific Title of Study
|
Validation of non-contact based vitals screening technology in effective triaging of patients visiting Kasturba Hospital- Manipal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muralidhar Varma |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College And Hospital |
| Address |
Department of Infectious Diseases, Kasturba Medical College and Hospital. Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9845069639 |
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muralidhar Varma |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College And Hospital |
| Address |
Department of Infectious Diseases, Kasturba Medical College and Hospital. Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9845069639 |
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muralidhar Varma |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College And Hospital |
| Address |
Department of Infectious Diseases, Kasturba Medical College and Hospital. Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9845069639 |
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College. Manipal Academy Of Higher Education. Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education_Kasturba Medical College Manipal |
| Address |
Madhav Nagar, Manipal-576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Philips India Limited |
Philips Innovation center Bangalore, Manyata Tech Park, Outer Ring Rd, Nagavara, Bengaluru, Karnataka 560045 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Muralidhar Varma |
Kasturba Medical College. Manipal |
Room No.15,
Department of Infectious Diseases.
Ground floor.
Madhav Nagar. Manipal-576104
Udupi
KARNATAKA |
08202923875
muralidhar.varma@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X||New Technology, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)All the clients (patients and patient caretakers) of Kasturba Hospital who are waiting for their entry into the hospital premises.
2)Both the genders of age group between 5 years to 80 years who can sit in the wheel chair and can walk independently and the care takers of the primary patient.
|
|
| ExclusionCriteria |
| Details |
1)Unconscious, mentally challenged, non-comprehending patients and patients who are confined to stretchers.
2)Infants and children of age below 5 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The accuracy of the non-contact health screening technology will be significantly higher (60-75 percent) compared to a simple IR thermometer in identifying patients with a respiratory infection
2)The algorithm of non-contact health screening technology will be able to quantify the severity of sickness formulate an effective triaging protocol for pre-symptomatic, early symptomatic, moderate to severely infected Covid-19 other respiratory infection patients |
1)The recorded data will be analyzed, interpreted, findings will be reviewed every 15 days during the initial 6 months
2)Once the expert team is confident about the data accuracy, the findings were subjected to analysis at the end of every 8 weeks to test the primary outcomes.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Noncontact health screening technology will be able to reduce 50 to70 percent spread of infection from respiratory infected patients to others visiting hospitals
Noncontact screening technology will be able to reduce the screening time by 50 percent less compared to conventional screening procedure
Noncontact technology will help the better utilization of nurses, doctors for more deserving areas - inpatient care surgical theaters human intervention is irreplaceable. |
Efficacy of the kiosk for the intended function its secondary benefits will be analyzed & reviewed at the end of every one year.
The findings will be discussed with the experts the necessary modifications will be undertaken to improve the efficacy of the technology |
|
|
Target Sample Size
|
Total Sample Size="6800"
Sample Size from India="6800"
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)
|
29/08/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to validate the newly developed screening technology that can measure heart rate, respiratory rate and body temperature without any physical contact and can predict the status of patient’s health and wellness. The data obtained from this technology will be compared with the conventional method of recording with physical contact to assess the accuracy of new technology. We the team of Kasturba hospital doctors and medical devices engineering experts have developed a new technology than can measure a person’s heart rate, respiratory rate and body temperature without touching their body. We believe that, this technology will reduce the risk of any cross infection among the fellow patients and doctors, nurses and other hospital staffs. This technology also will help the hospital team to effectively screen persons for COVID19 and other respiratory infections and can identify the severity of underlying illness in persons who is sick and needs immediate treatment. This technology can also identify the persons with COVID19 infection even at very early stage and help them to get early treatment. Apart from screening for infections, this technology can also tell us about general body health and wellness to enable us to treat patient effectively. All the government guidelines are strictly followed for the safety of health care workers and the participants of the study. This technology will record video for one minute and will derive all vital parameters (heart rate , respiratory rate and body temperature) from the recorded video. |