| CTRI Number |
CTRI/2024/01/061082 [Registered on: 03/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining how continuous monitoring with early warnings benefit hospital patients |
|
Scientific Title of Study
|
Evaluating the Impact of Continuous Remote Patient Monitoring and Early Warning System on Patient Outcomes in General Hospital Wards |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aby Abraham |
| Designation |
Professor and Head Department of Hematology |
| Affiliation |
Christian Medical College |
| Address |
Room no 23
A501
5th floor
A Block
Department of Hematalogy
Christian Medical College and Hospital
Ranipet Campus
Ratnagiri
Kilminnal
Tamil Nadu
Vellore
TAMIL NADU
632517
India |
| Phone |
04162282352 |
| Fax |
|
| Email |
aby@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Chokalingam |
| Designation |
Senior Clinical Research Manager |
| Affiliation |
Turtle Shell Technologies Pvt Ltd |
| Address |
Department of Clinical Research
Ground floor
40 City Centre
Nomads Daily Huddle
Chinmaya Mission Hospital Rd
Indiranagar
Bengaluru
Bangalore
KARNATAKA
560038
India |
| Phone |
9008349922 |
| Fax |
|
| Email |
kumar.chokalingam@dozee.io |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumar Chokalingam |
| Designation |
Senior Clinical Research Manager |
| Affiliation |
Turtle Shell Technologies Pvt Ltd |
| Address |
Department of Clinical Research
Ground floor
40 City Centre
Nomads Daily Huddle
Chinmaya Mission Hospital Rd
Indiranagar
Bengaluru
Bangalore
KARNATAKA
560038
India |
| Phone |
9008349922 |
| Fax |
|
| Email |
kumar.chokalingam@dozee.io |
|
|
Source of Monetary or Material Support
|
| Turtle Shell Technologies Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Turtle Shell Technologies Pvt Ltd |
| Address |
City Centre
40 Ground and Mezzanine flr
Nomads Daily Huddle
Chinmaya Mission Hospital Rd
Indiranagar
Bengaluru |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
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 Aby Abraham |
Christian Medical College |
Stem Cell transplant unit
D603 and D604
6th floor D Block
Urology ward
C502
5th floor C Block
Neurosurgery ward
C402
4th floor C Block
Pulmonary medicine ward
C202
2nd flooor C Block
Hepatobiliary ward
B601
6th floor B block
Christian Medical College
Ranipet campus
Ratnagiri Kilminnal
Vellore
Vellore
TAMIL NADU |
04162282352
aby@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College, Vellore |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult (18 years old and more) ward patient admitted in one of the identified study wards
2. Weight between 40kg-120kgs
3. They or legal representative are able and willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Admitted for observation period of more than 4 hours
2. Weight below 40 kgs and above 120 kgs
3. Have any condition that could interfere with the subjects ability to lie flat or stable on the bed
4. Needs the use of equipments whose operation can interfere with Dozee signal
5. Patient not giving or unable to give consent
6. Pregnant
7. Patients with pacemakers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhanced Patient safety, Optimised health economics |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of usage |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
10/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recognizing and responding to signs of worsening health in hospital wards is a common problem. Due to the large number of patients, healthcare providers can only check vital signs every few hours, which can result in missed signs of deterioration. Digital adoption and remote patient monitoring have become important in healthcare, but continuous monitoring is not widely used outside critical care settings. Implementing continuous monitoring in general wards can lead to alarm fatigue and high false alarm rates, burdening caregivers and potentially putting patients at risk.
Dozee, developed by Turtle Shell Technologies (TST) Private Limited, is a validated system for remote patient monitoring. It uses non-invasive sensors to continuously monitor heart rate, respiration rate, blood pressure, ECG rhythm, temperature and SpO2. Dozee goes beyond traditional patient monitors by delivering EWS Alerts based on customized algorithms using the above vital values. These alerts consider the overall patient condition, reducing excessive alerts and alarm fatigue. This clinical study aims to assess the impact of Dozee’s EWS Alerts on patients’ clinical outcomes. The study will be conducted in two phases. In the first phase, the correlation between Dozee’s EWS Alerts, on patient outcomes will be examined. No clinical actions will be taken based on the alerts during this phase and the present standard of care will be followed in the study wards. In the second phase, interventions will be taken based on Dozee’s Alerts, and the outcomes will be documented. A comparative analysis between the two phases will provide insights into the impact of Dozee on healthcare delivery and patient outcomes. |