| CTRI Number |
CTRI/2022/09/045271 [Registered on: 06/09/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dozee device validation for vitals monitoring |
|
Scientific Title of Study
|
Validation of the Dozee System |
| Trial Acronym |
DZ_SP_VAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumar Kenchappa |
| Designation |
Consultant Interventional Cardiologist |
| Affiliation |
SPARSH Super Specialty Hospital |
| Address |
SPARSH Super Specialty Hospital
146, Infantry Rd,
Vasanth Nagar,
Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
8861499206 |
| Fax |
|
| Email |
drkumarkenchappa@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 City Centre, 40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru
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 City Centre, 40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru
Bangalore
KARNATAKA
560038
India |
| Phone |
|
| Fax |
|
| Email |
pooja@dozee.io |
|
|
Source of Monetary or Material Support
|
| Turtle Shell Technologies Private Limited
City Centre, #40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038 |
|
|
Primary Sponsor
|
| Name |
Turtle Shell Technologies Private Limited |
| Address |
City Centre, #40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038 |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kumar Kenchappa |
SPARSH Super Specialty Hospital |
Room number 10, Ground floor OPD,Prestige Opal # 146, Infantry Rd, Opposite to police commissioners office
Vasanth Nagar,
Bengaluru- 560001
Bangalore
KARNATAKA |
8861499206
drkumarkenchappa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sparsh Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Validation of vitals including HR, HRV, RR, temperature, SpO2, BP, heart rhythm, posture, motion (movement accuracy and bed exit
accuracy) |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting adults (>18 years old) who are healthy individuals or patients undergoing treatment in the hospital (OPD, General wards, Emergency wards)
2. Weight between 40kg-150kgs
3. They/legal representative are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Weight below 40 kgs and above 150 kgs
2. Currently pregnant
3. Exhibit injuries, deformities, or other abnormalities that, in the opinion of the investigator, may prevent proper placement of accessories
4. Level of agitation or non-compliance too high to enroll
5. Needs the use of equipments whose operation can interfere with Dozee’s signal
6. A significant medical condition in the judgment of the investigator, which may compromise the study testing procedures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean absolute Error (MAE) of Dozee’s vitals parameters, HR, HRV, RR, BP, Temperature and SpO2 in comparison with the gold standard and or
equivalent devices
2. Motion Notification Accuracy (%), Bed Exit Notification Accuracy and
Posture Accuracy (%) of the Dozee in comparison with equivalent devices and manual observations.
3. Dozee’s sensitivity in the detection of heart rhythms in comparison with the gold standard method. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dozees detection rate and/or detection range of HR, HRV, RR, BP, SpO2, cardiac rhythms in comparison to the gold standard and/or equivalent
devices in various hospital bed/mattress setups and environmental conditions. |
At Baseline |
|
|
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)
|
12/09/2022 |
| 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="1"
Months="0"
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
|
The most common parameters supervised by healthcare professionals to
monitor patients’ health are heart rate (HR), heart rate variability (HRV),
respiration rate (RR), oxygen saturation (SpO2), temperature, blood pressure
(BP), and heart rhythm [1]. Existing gold standard methods for measuring HR,
HRV and RR necessitate the use of multi-lead ECG sensors [2] and nasal
thermistor/nasal cannulas [3], which are both cumbersome and require a high
level of patient compliance. These methods, too, necessitate some clinical
expertise for proper application. Many advances have been made in the use of
wearables to achieve long-term monitoring of vitals [4,5]. However wearables
also require a high level of patient compliance. 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. 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 HR, RR, and SpO2 (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 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. This device is intended to be used to
monitor individuals/patients greater than eighteen years of age (between
40kg-150kgs) and can measure their vital signs during sleep and resting state.
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
validating the effectiveness of the investigational device in a general-care
clinical environment. 1. Dias D, Paulo Silva Cunha J. Wearable Health Devices-Vital Sign
Monitoring, Systems and Technologies. Sensors (Basel). 2018 Jul
25;18(8):2414. doi: 10.3390/s18082414. PMID:30044415; PMCID: PMC6111409. 2. Sandau KE, et.al., American Heart Association Council on
Cardiovascular and Stroke Nursing;Council on Clinical Cardiology; and Council
on Cardiovascular Disease in the Young. Update to Practice Standards for
Electrocardiographic Monitoring in Hospital Settings: A Scientific
Statement From the American Heart Association. Circulation. Nov
7;136(19):e273-e344.(2017) 3. Subbe, Christian Peter & Kinsella, Sean. (2018). Continuous
Monitoring of Respiratory Rate in Emergency Admissions: Evaluation of the
RespiraSenseTM Sensor in Acute Care Compared to the Industry Standard and
Gold Standard. Sensors. 18. 2700. 10.3390/s18082700. 4. 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
5. 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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