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CTRI Number  CTRI/2024/10/074587 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Comparison of Vital Sign Monitoring using Wearable Biosensor versus standard patient monitor  
Scientific Title of Study   Comparative Evaluation of Continuous Vital Sign Monitoring in Intensive care unit: Standard ICU Monitor Versus UbiqVue 2A Wireless Patient Monitoring System with Wearable Biosensor  
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 Mathangi Krishnakumar 
Designation  Associate Professor 
Affiliation  St John’s Medical College Hospital 
Address  Ground Floor, Room No. 02, Department of Anaesthesia, St Johns Medical College Hospital, Sarjapur Road, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  mathangidoc@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mathangi Krishnakumar 
Designation  Associate Professor 
Affiliation  St John’s Medical College Hospital 
Address  Ground Floor, Room No. 02, Department of Anaesthesia, St Johns Medical College Hospital, Sarjapur Road, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9764062212  
Fax    
Email  mathangidoc@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Mathangi Krishnakumar 
Designation  Associate Professor 
Affiliation  St John’s Medical College Hospital 
Address  Ground Floor, Room No. 02, Department of Anaesthesia, St Johns Medical College Hospital, Sarjapur Road, Bangalore


KARNATAKA
560034
India 
Phone  9764062212  
Fax    
Email  mathangidoc@outlook.com  
 
Source of Monetary or Material Support  
LifeSignals India Pvt. Ltd. 3rd Floor, Ajmera Aditya Summit, 7th C Main Road, 3rd Cross Road, Koramangala 3rd Block Bangalore 560034  
 
Primary Sponsor  
Name  LifeSignals India Pvt Ltd 
Address  3rd Floor, Ajmera Aditya Summit, 7th C Main Road, 3rd Cross Road, Koramangala 3rd Block Bangalore 560034  
Type of Sponsor  Other [Medical Device Manufacturer] 
 
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 Mathangi Krishnakumar  St Johns Medical College Hospital  Ground Floor, Room No. 02, Department of Anaesthesia, St Johns Medical College Hospital, Sarjapur Road, Bangalore
Bangalore
KARNATAKA 		 9764062212

mathangidoc@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical College Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Philips MP70 - ICU patient Monitor   Adult patients meeting the inclusion criteria will be monitored simultaneously with both the standard ICU monitor (Philips MP70) and the UbiqVue 2A Wireless Patient Monitoring System for a duration of up to 48 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Adult patients (18 years or older) admitted to the ICU.
2. Patients having an invasive arterial monitor (radial or femoral) as per their clinical condition.
3.Male and female
 
 
ExclusionCriteria 
Details  1. Participants with active implantable medical devices such as pacemakers or implanted defibrillators.
2. Participants exposed to magnetic resonance (MR) environment.
3. Participants allergic to adhesive, electrode gel or non-woven materials.
4. Women with pregnancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess whether the UbiqVue 2A wireless patch system is able to reliably measure vital signs continuously in the clinical setting, and to determine how well it compares to recorded measurements in standard ICU monitor.  Continuous data will be recorded from both devices for up to 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
aims to compare the accuracy and reliability of continuous vital sign monitoring using a standard ICU monitor with the UbiqVue 2A Wireless Patient Monitoring System over a 48-hour period.   Continuous data will be recorded from both devices for up to 48 hours 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
  • The UbiqVue 2A Wearable Biosensor will be attached to the patient chest. It is a sensor which needs to be placed on the chest through medical grade adhesive similar to a chest electrode following the manufacturer’s instructions.
  • Vital parameters (ECG, Heart Rate, SpO2, Pulse Rate, PPG, Invasive BP) will be continuously monitored using both the standard ICU monitor and the UbiqVue 2A Wireless Patient Monitoring System.
  • The values will be taken from the monitor for comparison
  • The clinician will not make treatment decisions based on the wireless monitor data; it will only be used for comparison purposes.
 
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