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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1. Lead Time
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 85.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients Age greater than or equal to 18 years
- •Patients Admitted to General Wards, IMCU B,under hospital monitored home care,or transported via hospital ambulance services,
- •Patients Expected to remain under hospital supervision for more than 24 hours
- •Patients who are able and willing to provide consent.
Exclusion Criteria
- •Participants will be excluded if they:
- •Are directly admitted to ICU at the time of patch placement
- •Are designated as terminally ill directive
- •Are under end-of-life care support
- •Have known persistent arrhythmias, pacemakers, or ECG interference (e.g., excessive motion artifacts)
- •Decline or are unable to provide informed consent
- •Have incomplete medical records or leave against medical advice during patch monitoring
- •Post cardiac transplant patients.
Outcomes
Primary Outcomes
1. Lead Time
Time Frame: 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
(Threshold
Time Frame: 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
Alert)
Time Frame: 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
2. Time to
Time Frame: 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
Treatment
Time Frame: 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
3. RRT
Time Frame: 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
Activation
Time Frame: 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
Rate
Time Frame: 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
4. Code Blue
Time Frame: 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
Incidence
Time Frame: 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
5. Unplanned
Time Frame: 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
ICU Transfers
Time Frame: 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
6. In-Hospital
Time Frame: 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
Mortality
Time Frame: 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
7. Hospital
Time Frame: 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
Length of
Time Frame: 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
Stay
Time Frame: 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 Outcomes
- 1. Alert(Frequency per)
Investigators
Dr Mohan R
PSG Institute of Medical Sciences and Research