| CTRI Number |
CTRI/2022/09/045901 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dozee device validation for continuous vitals monitoring |
|
Scientific Title of Study
|
Validation of continuous monitoring of body vitals by Dozee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DZ_AP_VIT Version 1.0 dated 17 Aug 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddartha Reddy |
| Designation |
Consultant critical care medicine |
| Affiliation |
Apollo Hospital |
| Address |
Medical Intensive Care Unit-II, Oncology building, 4th floor, Doctors room, Apollo Hospitals, Jubilee hills
Hyderabad
TELANGANA
500096
India |
| Phone |
9704033335 |
| Fax |
|
| Email |
siddarthareddyk@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 |
9611197910 |
| 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 |
9611197910 |
| 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 Siddartha Reddy |
Apollo Hospitals |
Medical Intensive Care Unit-II, Oncology building, 4th floor, Doctors room, Apollo Hospitals, Jubilee hills, Hyderabad-500096
Hyderabad
TELANGANA |
9704033335
siddarthareddyk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Clinical Studies, Apollo Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dozee |
Ballistocardiography non contact device for patient monitoring |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults Male or female. (Above 18 years of age)
2. Provide written informed consent.
3. Weight between 40kg/88.18lbs and 120kg/264.55lbs
4. Are stable ICU patients or patients admitted in wards |
|
| ExclusionCriteria |
| Details |
1. Are connected to a device that may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. A likely need to receive or undergo a procedure during the testing period.
4. Cannot accept a nasal cannula or have a monitor lead placed on the chest.
5. Have a significant medical condition in the judgement 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 of Dozee’s Heart Rate and Gold Standard Devices heart rate
2. Mean Absolute Error of Dozee’s Respiratory Rate and Gold Standard Devices Respiratory rate |
At Baseline at the time of patient enrolment into the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Root Mean Square Difference of Dozee’s Heart Rate and Gold Standard Devices heart rate
2. Root Mean Square Difference of Dozee’s Respiratory Rate and Gold Standard Devices Respiratory rate |
At Baseline at the time of patient enrolment into the study |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/10/2022 |
| 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="0"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 present study aims to:
1. Validate Dozee HR and RR considering Patient Monitor
as gold standard.
2. Verify the EarlySense System HR and RR
considering Patient Monitor as gold standard.
3. The study separately intended to show a
non-inferiority trial of the Investigational device with the Predictive device
i.e EarlySense System.
Dozee device developed
by Turtle Shell Technologies Pvt. Ltd., is intended for contactless continuous
monitoring of vital parameters (HR and RR), and screening for abnormal changes
in these parameters. 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 device is intended to be used to monitor
individuals/patients greater than eighteen years of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signs
during sleep and resting state. The setup includes placing a sensor under the
mattress, and a bedside unit on a nearby flat surface. The other components of
the setup are Power cords and Power adapter. Thus, a power outlet with
sufficient plug sockets near the bed will be required. |