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CTRI Number  CTRI/2022/08/044885 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 16/03/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Investigator Initiated Study 
Study Design  Other 
Public Title of Study   Monitoring of Core body temperature, Heart rate (HR) and Respiration rate (RR) 
Scientific Title of Study   Bravo1 Patient Monitor (PM) Platform: Core Body Temperature, Heart Rate and Respiration Rate Validation  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Venkateshwar Rao 
Designation  Principal Investigator 
Affiliation   
Address  St. Theresas Hospital, Sanathnagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  9440040662  
Fax    
Email  drvenkateshwarraoavula@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Venkateshwar Rao 
Designation  Principal Investigator 
Affiliation   
Address  St. Theresas Hospital, Sanathnagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  9440040662  
Fax    
Email  drvenkateshwarraoavula@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Naresh Chandra 
Designation  Director 
Affiliation  KS Bio Clinserve Pvt Ltd 
Address  Apeejay Business Center, Tresorie, Suite No-10, The Park, 22 Rajbhavan Road, Somajiguda, Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9000323366  
Fax    
Email  Naresh@ksbioclinserve.com  
 
Source of Monetary or Material Support  
BraveHeart Wireless Inc BHW 
 
Primary Sponsor  
Name  BraveHeart Wireless Inc BHW 
Address  11 Perimeter Road,Nashua,NH,03063,USA 
Type of Sponsor  Other [Medical Device Company] 
 
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 A Venkateshwar Rao  St Theresas Hospital  Sanathnagar,Hyderabad
Hyderabad
TELANGANA 		 9440040662

drvenkateshwarraoavula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Theresas Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  •All subjects shall be at least 18 years or older.
•In good general health without any evidence of medical issues and/or problems.
•The subject must have the ability to understand and provide written informed consent.
•The subject must be willing and able to comply with study procedures and duration.
•Male or female of any race but a wide demographic across age, gender and race is preferred.
•It is required, by ISO 80601-2-56, that 30% - 50% of subjects shall be recruited that demonstrate
as febrile from the population of all subjects identified for the study.
•A febrile subject is someone having:
â–ª An elevated core temperature of 38.0 Dec C (100.4 Deg F) or higher as measure by the Reference Clinical Thermometer (RCT).
â–ª An elevated sublingual temperature of 37.5 Deg C (99.5 Deg F) or higher as measured by the RCT, or
â–ª An elevated axillary temperature of 37.2 Deg C (99.0 Deg F) or higher as measured by the RCT.
 
 
ExclusionCriteria 
Details  •The subject is a current smoker
•The subject is pregnant, lactating or trying to get pregnant.
•The subject has a known history of heart disease, lung disease, kidney or liver disease.
•Diagnosis of asthma, sleep apnea, or use of CPAP.
•Diagnosed or self-reported respiratory diseases/impairment.
•Diagnosed or self-reported cardiovascular diseases/impairment.
•Subjects with inflammation at the measuring site.
•Subjects that have taken antipyretics in the preceding 120 min.
•Subjects meeting contraindications for device
•Subjects showing inflammation or skin damage at the measuring site (i.e., if site selection has open wounds, erythema, redness, old scar/wounds)
•Subjects with known skin allergies (e.g., silicone or hydrocolloid adhesives and/or hydrogel)
•The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
•The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Respiration Rate Data collected on the ML Explorer app.
• HR data collected on the ML Explorer App.
• Core body Temperature Data recorded from the reference clinical thermometer
(RCT) as noted against the Bravo1 PM Platform skin temperature results.
• Respiration Rate Data collected with the CapnosteamTM20p Portable Bedside
Monitor Capnograph.
• Multi-modality bio signals (PPG, temperature, motion) collected with ADI Fenda
and SpO2 watches.
 		 1.5 Hours
 
 
Secondary Outcome  
Outcome  TimePoints 
• Respiration Rate Data collected on the ML Explorer app.
• HR data collected on the ML Explorer App.
• Core body Temperature Data recorded from the reference clinical thermometer
(RCT) as noted against the Bravo1 PM Platform skin temperature results.
• Respiration Rate Data collected with the CapnosteamTM20p Portable Bedside
Monitor Capnograph.
• Multi-modality bio signals (PPG, temperature, motion) collected with ADI Fenda
and SpO2 watches.
 		 1.5 Hours 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/08/2022 
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="10"
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  

The purpose of this protocol is to perform clinical validation activities for the monitoring of core
body temperature, heart rate (HR) and respiration rate (RR) for the BraveHeart Wireless, Inc. (BHW)
Bravo1 Patient Monitor (PM) Platform.
Additionally, to simultaneously conduct data collection activities for temperature and RR monitoring
of the Analog Devices (ADI) Fenda and SpO2 watches in the spirit of a Joint Development Agreement
executed between BHW and ADI.
To collect, evaluate, compare and validate clinically obtained core body temperature results, as
measured by a known FDA cleared digital thermometer (utilizing traditional and generally
accepted clinical methods) against the non-invasive, chest worn Bravo1 PM Platform skin
temperature results for all study subjects.
To collect, evaluate, compare and validate clinical RR monitoring results for the Bravo1 PM
Platform against known FDA cleared reference devices utilizing nasal/oral-worn capnography
and/or finger-worn photoplethysmography (PPG) for all study subjects.


 
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