| CTRI Number |
CTRI/2024/07/070541 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study to checking if VIGO vitals solution can accurately predict health emergencies early |
|
Scientific Title of Study
|
Validation of early warning score using VIGO vitals solution |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Kumar Bandaru |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
4th Floor, Department of General Medicine, Medical College Hospital, Sanathnagar, Hyderabad
Hyderabad
TELANGANA
500036
India |
| Phone |
9885633040 |
| Fax |
|
| Email |
drrajivb85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Kumar Bandaru |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
4th Floor, Department of General Medicine, Medical College Hospital, Sanathnagar, Hyderabad
Hyderabad
TELANGANA
500036
India |
| Phone |
9885633040 |
| Fax |
|
| Email |
drrajivb85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajiv Kumar Bandaru |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
4th Floor, Department of General Medicine, Medical College Hospital, Sanathnagar, Hyderabad
Hyderabad
TELANGANA
500036
India |
| Phone |
9885633040 |
| Fax |
|
| Email |
drrajivb85@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Sanathnagar, Hyderabad, Telangana, India- 500036 |
|
|
Primary Sponsor
|
| Name |
Dr Rajiv Kumar Bandaru |
| Address |
4th Floor, Department of General Medicine, Medical College Hospital, ESIC Medical College, Sanathnagar, Hyderabad |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajiv Kumar Bandaru |
ESIC Medical College and Hospital |
Room No 406, 4th Floor, Department of General Medicine, Medical College Hospital Block,Sananthnagar
Hyderabad
TELANGANA |
9885633040
drrajivb85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ESIC Medical College and Hospital and ESIC Super speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
The vitals measured through standard methods and early warning signals generated through NEWS-2 score by physician |
at 0,6,12,24,30,36, 48 hours respectively |
| Intervention |
Vigo Solution |
The vitals and early warning signals will be continuously generated |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderately ill patients
2. step down ICU patients |
|
| ExclusionCriteria |
| Details |
1. critically ill patients
2. ICU patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The correlation of AI generated warning signals verses Physician generated National Early Warning Score (NEWS) |
0,6,12,24,30,36,48 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The correlation of vigo solution generated vitals (PR, HR, RR, Temperature, BP, SpO2) verses Standard methods generated vitals |
0,6,12,24,30,36,48 Hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study is conducted to validate a multi-vital monitoring device called as vigo (Vitals in a go) solutions that measures Respiratory rate, pulse rate, heart rate, blood pressure,oxygen saturation and temperature, the vitals recorded will be transfered with the help of cloud technology through app to treating physician and command center continuously, Artificial intelligence based early warning signal will be generated to alert during the time of emergency. The AI Based results will be compared with standard procedure based results for degree of correlation.
|