FindTrial
Sign In

A study to monitor patients continuously using wearable sensors and standard scores to detect early warning signs of serious illness during hospital stay

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092139
Enrollment
100
Registered
2025-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems

Interventions

Intervention1: Nil: Nil

Sponsors

PSG Institute of Medical Sciences and Research and Hospitals
Lead Sponsor
L S DEVICES PRIVATE LIMITED
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 Timepoint: 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

MeasureTime frame
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 Timepoint: 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.—

Countries

India

Contacts

Public ContactDr Mohan R

PSG Institute of Medical Sciences and Research

mohan@psgimsr.ac.in9994749580

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026