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CTRI Number  CTRI/2022/04/041712 [Registered on: 07/04/2022] Trial Registered Prospectively
Last Modified On: 18/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Remote vitals monitoring]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Study to check the accuracy and precision of Real Time Multi Vital Monitoring solution in comparison with standard vital monitoring methods. 
Scientific Title of Study   Validity of Real Time Multi Vital Monitoring using Remote monitoring Technology: A pilot Study 
Trial Acronym   
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  Department of General Medicine,4th Floor, Ward Block, Medical College Hospital, Sanathnagar, Hyderabad.

Hyderabad
TELANGANA
500038
India 
Phone    
Fax    
Email  drrajivb85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mehdi Ali Mirza 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and Hospital 
Address  Department of Pharmacology, 4th Floor, Right Wing, Academic and Administrative Block, Sanathnagar, Hyderabad.

Hyderabad
TELANGANA
500038
India 
Phone    
Fax    
Email  mehdialimirza@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sudha Bala 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and Hospital 
Address  Department of Community Medicine, 4th Floor, Left Wing, Academic and Administrative Block, Sanathnagar, Hyderabad.

Hyderabad
TELANGANA
500038
India 
Phone    
Fax    
Email  dr.sudhabala78@gmail.com  
 
Source of Monetary or Material Support  
Vigo Care Pvt.Ltd 
 
Primary Sponsor  
Name  Vigo Care PvtLtd 
Address  4th Floor, Trendz Trident, Jubilee Enclave, Madhapur, Hyderabad- 500081 
Type of Sponsor  Other [Health Care Technology] 
 
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 Rajiv Kumar Bandaru  ESIC Medical College and Hospital  Department of General Medicine, 4th Floor, Ward Block, Medical college Hospital, Sanathnagar Hyderabad.
Hyderabad
TELANGANA 		 9885633040

drrajivb85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ESIC Medical College and Hospital IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy males with vital Parameter, Lab study, ECG and chest x-ray under normal. 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Real Time Multi vital monitoring (RTMVM) solution   RTMVM is an artificial intelligence and cloud based technology based solution that continuously records vitals including BP, PR, RR, Temperature, SpO2 and lead 2 ECG. 
Comparator Agent  Standard methods for vital measurements including- Manual method for PR and RR, Sphygmomanometer for BP recording, Pulse oxymeter for SPO2, Conventional 12 lead ECG for for lead 2 reference.   The vitals will be compared with TMVM at following time points- 0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours respectively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy Volunteers

1.Healthy, adult male aged 18-45 years, with BMI 18.5- 25kg/m2
2.Subjects of normal health as determined by medical history and physical examination.
3.Subjects with screening lab values within normal limits or considered insignificant by physician / investigator.
4.Should comply with all study procedures

Patient:

1.Known CAD patient, stable on treatment.
2.Either gender and aged 18 to 65 years.
3.Should comply with all study procedures 
 
ExclusionCriteria 
Details  Healthy volunteers

1.History of Contact dermatitis or hypersensitivity to patch material.
2.Regular smoker and has difficulty abstaining from smoking for 48 hours before study
3.Subjects with clinically significant physical disabilities

Patients

1.History of Contact dermatitis or hypersensitivity to patch material.
2.Regular smoker and has difficulty abstaining from smoking for 48 hours before study
3.Subjects with clinically significant physical disabilities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Correlate the vitals including temperature, heart rate, respiratory rate, oxygen saturation, ECG derived from MVM solution and Standard methods in healthy volunteers.
 		 0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours respectively. 
 
Secondary Outcome  
Outcome  TimePoints 
Correlate the vitals including temperature, heart rate, respiratory rate, oxygen saturation, ECG derived from MVM solution and Standard methods in Coronary heart disease patients.  0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours receptively. 
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
Final Enrollment numbers achieved (Total)= "196"
Final Enrollment numbers achieved (India)="196" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/04/2022 
Date of Study Completion (India) 30/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Healthy volunteers:

 After taking the screening consent, subject will be examined by complete physical, clinical examination and laboratory screening investigation (CBP, FBS, RFT, LFT, CUE, Viral markers for HIV, HBsAg, HCV, ECG, Chest X-ray).  The participants will be screened for COVID-19 through RTPCR methods 24 hours prior to the start of study. Once the subject is found eligible,  the study procedure will be explained in detail and  written informed consent will be obtained.  The subjects will be instructed to refrained from smoking and caffeine containing beverages at least 24 hours before the study measurements. If all the eligibility criteria are met the  subjects will be asked to report to the study site 12 hours prior to the study and will be in-housed overnight.

On the study day the procedure will be started after overnight fasting for 10 hours. The on-boarding with MVM solution will be performed in the morning, in a quite room with controlled temperature  and continued for 24 hours. Then participant  will be asked to sit comfortably on a chair for 2 hrs. Then vitals using the standard methods will be recorded periodically at -1, 0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours respectively. To the participant, standard breakfast will be served after 2 hours and lunch at 6 hours post on-boarding. Subject will be kept at the research site until 24 hours. If the vitals are normal the subject will be allowed to discharge 30 minutes after off-boarding.

Patients:

The  patients with confirmed diagnosis of coronary artery disease and stable on medication will be screened by complete physical, clinical examination and laboratory investigation (CBP, FBS, RFT, LFT, CUE, Viral markers for HIV, HBsAg, HCV, ECG, Chest X-ray). The patients will be screened for COVID-19 through RTPCR methods 24 hours prior to the start of study. If found to be eligible the MVM solution and Standard measurements will be obtained in the similar way as in the healthy volunteers for 24 hours under direct and continues supervision of the physician.

 
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