| CTRI Number |
CTRI/2021/03/031841 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
validational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Non-contact kiosk for screening COVID19 |
|
Scientific Title of Study
|
Validation of non-contact health screening kiosk for COVID19 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 |
Associate professor , Department of infectious disease |
| Affiliation |
KMC Manipal, MAHE |
| Address |
Department of Infectious Diseases
KMC Manipal
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muralidhar Varma |
| Designation |
Associate professor , Department of infectious disease |
| Affiliation |
KMC Manipal, MAHE |
| Address |
Department of Infectious Diseases
KMC Manipal
Manipal
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muralidhar Varma |
| Designation |
Associate professor , Department of infectious disease |
| Affiliation |
KMC Manipal, MAHE |
| Address |
Department of Infectious Diseases
KMC Manipal
Manipal
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Tiger Circle Road, Madhav Nagar, Manipal |
| Philips Research, Philips Innovation Campus, Manyata Tech Park, Nagavara, Bangalore, Karnataka 560045, India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Manipal |
| Address |
Tiger circle road, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Philips Research |
Philips Research, Philips Innovation Campus, Manyata Tech Park, Nagavara, Bangalore, Karnataka 560045, India |
|
|
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 |
Infection control department of Kasturba Hospital
Udupi
KARNATAKA |
9845069639
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: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
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 the 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) Patients visiting the emergency triage
2) Unconscious, mentally challenged, non-comprehending patients and patients who are confined
to stretchers.
3) Pregnancy , infants and children of age below 5 years |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) The proposed non-contact health screening kiosk technology will be able to effectively identify
COVID19 patients with more accuracy compared to simple IR thermometer, which merely
measures the skin shell temperature. |
its only a single time point study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2) This technology based on its algorithm may formulate an effective screening and triaging
protocol for pre-symptomatic, early symptomatic and moderate to severely infected COVID19
patients. |
reading is measured immediately after screening the patient with device. (approximately 1 minute after screening) |
|
|
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)
|
20/03/2021 |
| 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="2"
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)?
Response - NO
|
|
Brief Summary
|
The current study is about to validate the efficacy of the novel non-contact health screening kiosk technology for COVID19
screening for 1) Reducing the relative physical proximity risk for the front line health care worker’s (HCW) to
COVID19 patients visiting KH during screening. 2) Better crowd management and reducing the chances of cross infection among the patients and
caretakers. 3) Developing better technology to screen and identify pre-symptomatic COVID patients. 4) Reducing patient screening time and hospital workflow time. 5) Identifying the severity of underlying disease and prevention of rapid deterioration without
measuring other vital parameters physically by the HCW’s. 6) Identifying the Geriatric / Immunosuppressed / Cancer/transplant COVID19 patients who may
present with atypical and non-classical COVID19 symptoms. |