| CTRI Number |
CTRI/2025/08/092139 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to monitor patients continuously using wearable sensors and standard scores to detect early warning signs of serious illness during hospital stay |
|
Scientific Title of Study
|
A Prospective Observational Study to Evaluate Early Detection of Clinical Deterioration Using Multiparameter Remote Monitoring and NEWS2-Based Manual Monitoring in a Tertiary Care Center |
| 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 Mohan R |
| Designation |
Assistant Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
2nd Floor, Old College Building, Department of Physiology, PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9994749580 |
| Fax |
|
| Email |
mohan@psgimsr.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan R |
| Designation |
Assistant Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
2nd Floor, Old College Building, Department of Physiology, PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9994749580 |
| Fax |
|
| Email |
mohan@psgimsr.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan R |
| Designation |
Assistant Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
2nd Floor, Old College Building, Department of Physiology, PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9994749580 |
| Fax |
|
| Email |
mohan@psgimsr.ac.in |
|
|
Source of Monetary or Material Support
|
| L S DEVICES PRIVATE LIMITED, Ground Floor No 25, Steeple Reach, Cathedral Road, Chennai, Tamil Nadu 600086, India |
|
|
Primary Sponsor
|
| Name |
PSG Institute of Medical Sciences and Research and Hospitals |
| Address |
Peelamedu, Coimbatore 641004, Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| L S DEVICES PRIVATE LIMITED |
Ground Floor No 25, Steeple Reach, Cathedral Road, Chennai, Tamil Nadu 600086, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohan R |
PSG Institute of Medical Sciences and Research and Hospital |
2nd Floor, Old College Building, Department of Physiology, PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore 641004,
Coimbatore
TAMIL NADU |
9994749580
mohan@psgimsr.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients Age greater than or equal to 18 years
2. Patients Admitted to General Wards, IMCU B,under hospital monitored home care,or transported via hospital ambulance services,
3. Patients Expected to remain under hospital supervision for more than 24 hours
4. Patients who are able and willing to provide consent
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they:
1. Are directly admitted to ICU at the time of patch placement
2. Are designated as terminally ill directive
3. Are under end-of-life care support
4. Have known persistent arrhythmias, pacemakers, or ECG interference (e.g., excessive
motion artifacts)
5. Decline or are unable to provide informed consent
6. Have incomplete medical records or leave against medical advice during patch
monitoring
7. Post cardiac transplant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Lead Time
(Threshold
Alert)
2. Time to
Treatment
3. RRT
Activation
Rate
4. Code Blue
Incidence
5. Unplanned
ICU Transfers
6. In-Hospital
Mortality
7. Hospital
Length of
Stay
|
1. Daily,2. Daily, 3.7days,4weeks,8weeks, 4.7days,4weeks,8weeks
5.7days,4weeks,8weeks
6. At Discharge or 8 weeks
7. At Discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Alert
Frequency per
Patient
2. False Alert
Rate
3. Clinical
Concordance
4. Lead Time
Advantage vs
NEWS2
5. Early Intervention
Incidence
6. Cross-setting
Feasibility
7. Staff Usability
Feedback
8. System
Specific Alert
Classification
9.Diagnosis
Associated
with Alert
10. Alert-to
Intervention
Correlation
11. Spot Check
Verification
Rate
12. Spot Check
Concordance
13. False Alert
Identification
via Spot
Check
14. NEWS2 vs
Dashboard
EWS
Monitoring
Concordance
15. Device Signal
Uptime
16. ECG
Deterioration
Events
17. Retrospective
Trend
Analysis Utility
|
Daily & cumulative at Week 4 & Week 8 for outcomes 1–5, 8, 9, 10–16. Outcome 6 at 8 weeks. Outcome 7 at Week 4 & 8. Outcome 17 at discharge & cumulative at Week 8. |
|
|
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)
|
11/08/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This Prospective observational study aims to evaluate the effectiveness of multiparameter remote monitoring using a wearable biosensor patch, combined with NEWS2-based manual monitoring, in the early detection of clinical deterioration across hospitalized patients, ambulance services, and home care settings of a tertiary care hospital. Conducted over 2-month period with a minimum sample size of 100 patients, the study will utilize certified wearable patches (monitoring heart rate, respiratory rate, ECG, Temperature) along with accessories for SpO2 and non - invasive blood pressure. Manual entries of temperature and level of consciousness will supplement the NEWS2 scoring. Data will be collected on alert parameters, system - specific classification, verification outcomes, interventions, and patient outcomes including ICU transfers, Code Blue events, in-hospital mortality, and hospital length of stay. ECG deterioration events, device uptime, and retrospective trend analyses will be included. Spot - check verifications and staff usability feedback will be captured. Ethics approval has been obtained, and the study complies with ICMR guidelines. The findings are intended to inform future monitoring strategies for timely recognition and response to clinical deterioration in diverse care settings. |