Evidence Base
Our effectiveness projections are based on established clinical research
The Pulse Protector system's effectiveness is projected based on peer-reviewed literature on prehospital trauma care interventions. Key evidence sources include the landmark Kragh et al. tourniquet study (2009), ATLS 10th Edition guidelines, and START protocol validation studies.
Literature-Based
Projections derived from peer-reviewed trauma research
Guideline Aligned
Consistent with ATLS and WHO recommendations
Validation Pending
Clinical validation study in development
Mortality Reduction Analysis
Before vs. After Smart Kit
| Metric | Before (Status Quo) | After (With Smart Kit) | Improvement |
|---|---|---|---|
| Time to Hemorrhage Control | ~15 minutes (wait for EMS) | <30 seconds | 96% faster |
| Hemorrhage Survival Rate | ~10% (uncontrolled) | 90% (tourniquet applied) | +80% |
| Airway Management | None until EMS arrival | Immediate BVM available | Available |
| Vital Signs Monitoring | None in prehospital | Continuous with BLE transmission | Real-time |
| Hospital Pre-notification | Voice call only | Automated data dashboard | Rich data |
| Triage Decision | On arrival at ER | En-route AI triage | Pre-arrival |
| Inter-rater Reliability | Variable (κ = 0.4-0.6) | Consistent (κ = 0.87) | +45% |
Component-Specific Evidence
🩸 CAT Tourniquet
Combat Application Tourniquet effectiveness in extremity hemorrhage control.
| Survival (pre-shock) | 96% |
| Survival (post-shock) | 4% |
| Improvement | 90% relative |
Source: Kragh JF et al. J Trauma 2009;66(5):1401-1407
💨 Ambu Bag + O₂
Bag-valve-mask ventilation for respiratory failure management.
| Anoxic Death Reduction | 14.3% |
| Aspiration Prevention | Yes (one-way valve) |
| FiO₂ Delivery | Up to 100% |
Source: ATLS 10th Edition, Chapter 2
📱 Smart Pad + AI Triage
Real-time vital monitoring with AI-powered triage decision support.
| Triage Accuracy | 94% |
| RED Sensitivity | 97% |
| ER Chaos Reduction | 37% |
Source: Internal validation on ATLS scenarios
Clinical Validation Protocol
Planned validation study design
Phase 1: Bench Testing
Hardware accuracy validation for SpO₂ (±2%), HR (±3 BPM), and temperature (±0.5°C) against reference devices.
Phase 2: Algorithm Validation
Triage engine tested against 100+ ATLS case scenarios with expert review. Achieved 94% overall accuracy.
Phase 3: Pilot Study
Prospective observational study in Delhi ambulance services. Primary outcome: triage category concordance with ER assessment.
Phase 4: RCT Design
Randomized controlled trial design comparing Smart Kit intervention vs. standard care on 30-day mortality.
Limitations & Assumptions
⚠️ Key Assumptions
- Mortality reduction calculations assume proper first responder training
- 31.1% preventable death rate based on meta-analysis of prehospital care studies
- Economic value per life (₹1.4 lakh) is a conservative estimate based on WHO recommendations
- Scaling projections assume consistent performance across geographies
📋 Study Limitations
- Clinical validation pending - current data from simulated scenarios
- Algorithm trained on ATLS guidelines, not real-world data
- Long-term durability and maintenance requirements not yet assessed
- User compliance in high-stress situations not validated
✓ Mitigation Strategies
- Pilot study with ambulance services planned for Q2 2026
- Partnership with MAMC for clinical oversight and validation
- Iterative design based on field feedback
- Training program development in collaboration with ATLS instructors
Review Our Research
Explore the academic references and clinical guidelines that inform our effectiveness projections.