| 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
|
|
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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
|
|
|
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
|
|
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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 |