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CTRI Number  CTRI/2022/02/040459 [Registered on: 21/02/2022] Trial Registered Prospectively
Last Modified On: 02/05/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Vitals monitoring in pediatric population 
Scientific Title of Study   A cross-sectional study for validation of heart rate, breathing rate, oxygen saturation level and temperature through the remote patient monitor of the pediatric population. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mallesh Kariyappa 
Designation  Professor and Head 
Affiliation  Bangalore Medical College and Research Insititute 
Address  Department of Pediatrics Vanivilas Hospital Bangalore Medical College and Research institute Fort Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9448176097  
Fax    
Email  drmalleshk2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pooja Kadambi 
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies 
Address  Turtle Shell Technologies Innovation and Clinical Research 1st Floor City Centre 40 Nomads Daily Huddle Chinmaya Mission Hospital Rd Indiranagar Bengaluru Karnataka 560038

Bangalore
KARNATAKA
560038
India 
Phone    
Fax    
Email  pooja@dozee.io  
 
Details of Contact Person
Public Query
 
Name  Pooja Kadambi 
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies 
Address  Turtle Shell Technologies Innovation and Clinical Research 1st Floor City Centre 40 Nomads Daily Huddle Chinmaya Mission Hospital Rd Indiranagar Bengaluru Karnataka 560038

Bangalore
KARNATAKA
560038
India 
Phone    
Fax    
Email  pooja@dozee.io  
 
Source of Monetary or Material Support  
Department of Pediatrics Vanivilas Hospital Bangalore Medical College and Research Institute Fort Bangalore Karnataka India 560002 
 
Primary Sponsor  
Name  Turtle Shell Technologies Private Limited 
Address  City Centre 40 Ground and Mezzanine floor Nomads Daily Huddle Chinmaya Mission Hospital Rd Indiranagar Bengaluru Karnataka 560038  
Type of Sponsor  Other [Medical Device] 
 
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 Mallesh Kariyappa  Victoria Hospital  Department of pediatrics Vanivilas Hospital Bangalore Medical College and Research Institute Fort Bangalore Karnataka India Pin code 560002
Bangalore
KARNATAKA 
9448176097

drmalleshk2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening for Heart Rate, Respiratory Rate, Oxygen Saturation and Temperature 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age: 1 month to 12 years children who needs monitoring
Both male and female
The subject’s parents are willing and able to give informed consent for the participation of their child in the study
 
 
ExclusionCriteria 
Details  Age less than 1 month and greater than 12 years
Children who are extremely agitated
Children in whom the device can’t be kept in situ
The subject’s parents are unable to or unwilling to give informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Root mean square deviation (RMSD) of the Dozee’s HR and Gold Standard Devices HR
2. Root mean square deviation (RMSD) of the Dozee’s RR and Gold Standard Devices RR
3. Root mean square deviation (RMSD) of the Dozee’s SpO2 and Gold Standard Devices SpO2
4. Root mean square deviation (RMSD) of the Dozee’s Temperature and Gold Standard Devices Temperature
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Not Applicable 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   28/02/2022 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Heart Rate (HR), Respiration Rate (RR), Temperature and Oxygen Saturation (SpO2) are the most common vital signs used by medical professionals to monitor health of the patients. While a pulse oximeter is mostly used only to capture oxygen saturation, it can also be used to measure heart  rate, though ECG remains the gold standard for heart rate measurement. Respiration, on the other hand, is traditionally measured manually by the nursing staff but can also be measured using a nasal thermistor or capnography. Monitoring of these vitals with less cumbersome techniques would be ideal in long term monitoring of patients and healthy people to detect any sudden abnormalities and long-term health deterioration. During COVID-19 pandemic, remote monitoring devices have come up as champions to assist the healthcare workers in patient monitoring. Several advancements have been made in achieving continuous long-term monitoring of vitals using wrist watches, PPG sensors, etc. [1, 2]. But very few of these have been implemented with acceptable accuracy. The Dozee device developed by Turtle Shell Technologies Pvt. Ltd., is a non-contact continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of HR, RR, and continuous measurement of SpO2 and Temperature (when connected with an accessory). The device uses the concept of ballistocardiography and deploys piezoelectric sensors to capture the micro-vibrations originating from cardiac contractions, upper respiratory tract activity and body movements. This data is then analyzed by a proprietary algorithm and the values of the vital parameters – HR and RR are generated. The sensor sheet is placed below the mattress and captures data while the user is resting or sleeping and does not require a sensor to be fixed to the body making it ideal when compared to current methods. Monitoring people’s vital signs outside an ICU often relies on nursing staff conducting checks at set intervals. The device can reduce the workload for nursing staff in non-ICU wards. The data can be viewed on the dashboard, exported, and even be directly transferred to the in-house hospital management software. This protocol aims at verifying the effectiveness of the investigational device in a general-care clinical environment and in ICU settings in a pediatric population.

References

1. Etiwy M, Akhrass Z, Gillinov L, et al. Accuracy of wearable heart rate monitors in cardiac rehabilitation [published correction appears in Cardiovasc Diagn Ther. 2020 Jun;10(3):644-645]. Cardiovasc Diagn Ther.2019;9(3):262-271. doi:10.21037/cdt.2019.04.08

2. Charlton PH, Bonnici T, Tarassenko L, Clifton DA, Beale R, Watkinson PJ. An assessment of algorithms to estimate respiratory rate from the electrocardiogram and photoplethysmogram. Physiol Meas. 2016;37(4):610-626. doi:10.1088/0967-3334/37/4/610

 
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