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Authorized Access Only • Blinded Aggregate Clinical Data
SafeBreak Registry Clinical ReportBreakaway Impact Registry Results
SIH Carbondale Hospital Clinical Dashboard
EnrolledSafeBreak Enrolled
148
Control Enrolled
340
SafeBreak Separation Rate
19.6%
SafeBreak Complication Rate
8.1%
Control Complication Rate
31.2%
Complication Rate Reduction
74%
CLINICALCLINICAL RESULTS
Active Filters
PIV-only records are shown.
Summary
| Metric | SafeBreak Group N (%) |
Control Group N (%) |
Aggregate SafeBreak Data N (%) |
Aggregate Control Data N (%) |
|---|---|---|---|---|
| Enrollment | 148 | 340 | — | — |
| Separations | 29 (19.6%) | — | — | — |
| Cohort IV Complications | 12 (8.1%) | 106 (31.2%) | — | — |
Outcome Improvement Metrics
| Metric | SafeBreak Group N (%) |
Control Group N (%) |
Aggregate SafeBreak Data N (%) |
Aggregate Control Data N (%) |
|---|---|---|---|---|
| Absolute Risk Reduction | 23.1% | — | — | — |
| Relative Risk Reduction | 74.0% | — | — | — |
| Risk Ratio (RR) | 0.26 | — | — | — |
| Number Needed to Treat | 4.3 | — | — | — |
Complication Types
| Type | Aggregate Control Data N (%) |
Aggregate SafeBreak Data N (%) |
Aggregate Complication Reduction |
|---|---|---|---|
| Dislodgement | — | — | — |
| Infiltration | — | — | — |
| Leaking | — | — | — |
| Occlusion | — | — | — |
| Phlebitis | — | — | — |
| All Complications | — | — | — |
Cause of Separation
| Cause | SafeBreak Group N (%) |
Control Group N (%) |
|---|---|---|
| Unknown | 19 (50%) | — |
| Pulled by Patient on purpose | 15 (39%) | — |
| Alligator Roll by Patient | 1 (3%) | — |
| Laying on tubing | 1 (3%) | — |
| Patient Transfer (bed to bed) | 1 (3%) | — |
| Tubing trapped in hospital bed/rail | 1 (3%) | — |
Note: Cause of separation may be multi-select; percentages may exceed 100%.
Statistical Comparison of IV Complication Rates
| Metric | Value | P-value | Significance |
|---|---|---|---|
| Two-proportion z-test | -5.51 | <0.000001 | Highly Significant |
| Fisher exact test | Confirmed | <0.000001 | Highly Significant |
| Chi-square test | 30.3 | <0.0001 | Significant |
SafeBreak Admission Diagnosis by Therapeutic Indication
| Therapeutic Indication | N | % |
|---|---|---|
| Gastrointestinal / Hepatobiliary | 15 | 20.8% |
| Orthopedic / Trauma / Musculoskeletal | 14 | 19.4% |
| Infectious Disease / Sepsis | 11 | 15.3% |
| Respiratory | 7 | 9.7% |
| Neurologic | 7 | 9.7% |
| Missing/Not Documented | 6 | 8.3% |
| Other / General Medical | 5 | 6.9% |
| Renal / Urologic | 4 | 5.6% |
| Cardiovascular | 3 | 4.2% |
Replacement Time Difference
(SafeBreak vs. IV)
(SafeBreak vs. IV)
—
Dwell Time Difference
(SafeBreak vs. Control)
(SafeBreak vs. Control)
—
Hospital Stay Difference
(SafeBreak vs. Control)
(SafeBreak vs. Control)
—
Catheter Ratio Difference
(SafeBreak vs. Control)
(SafeBreak vs. Control)
—
OPERATIONALOPERATIONAL RESULTS
Active Filters
PIV-only records are shown.
Working Metrics
| Metric | SafeBreak Group N |
Control Group N (%) |
Aggregate SafeBreak Data N (%) |
Aggregate Control Data N (%) |
|---|---|---|---|---|
| Replacement Time, Minutes | 4.6 | 21.7 | — | — |
| Dwell Time, Hours | 64.9 | 58.1 | — | — |
| Hospital Length of Stay, Hours | 69.6 | 74.4 | — | — |
| Catheter-to-Patient Ratio | — | — | — | — |
Access Preservation
| Metric | SafeBreak Group N |
Control Group N |
Aggregate SafeBreak Data N |
Aggregate Control Data N |
|---|---|---|---|---|
| Separations or Control Complications | 29 | 106 | — | — |
| New IV Required | 6 | 56 | — | — |
| New IV Not Required / Access Preserved | 23 | 50 | — | — |
| Access Preservation Rate, 95% CI | 79.30% | 47.20% | — | — |
$
Estimated Annual Net Direct Savings per Hospital
$48,902
↑
Return on Investment (ROI)
130%
✓
Estimated Annual Complications Avoided per Hospital
1,614
Estimated Annual Bed Hours Preserved per Hospital
33,547 hours
✓
Estimated Annual Nursing Hours Preserved per Hospital
3,495 hours
ECONOMICALECONOMIC RESULTS
Active Filters
PIV-only records are shown.
Annual IV Restart Cost Avoidance
| Metric | SafeBreak Group vs Control | Assumption / Calculations | Aggregate SafeBreak Data | Aggregate Control Data |
|---|---|---|---|---|
| Annual IV Catheter assumption | 6,989 | Assumption of 112 Beds | — | — |
| Estimated complications avoided | 1,614 | 6,989 × 31.2% = 2,181 expected complications − 6,989 × 8.1% = 566 expected SafeBreak complications | — | — |
| Estimated IV Restarts Avoided | 2,064 | 2,181 expected control restarts − 117 expected SafeBreak restarts (20.7%) = 2,064 IV restarts avoided | — | — |
| Estimated Ultrasound guided IV Restarts | 268 | 13% based on average required ultrasound in control data | — | — |
| Estimated PIV restart | 1,796 | Complications avoided − ultrasound guided | — | — |
| Metric | SafeBreak Group vs Control | Assumption / Calculations | Aggregate SafeBreak Data | Aggregate Control Data |
|---|---|---|---|---|
| Hard cost + Nursing Time per Ultrasound guided restart | $28,754 | 268 × ($43.21 + ($21.36 × 3)) = 268 × $107.29 | — | — |
| Hard cost + Nursing Time per PIV restart | $57,764 | (2,064 + (2,064 × 31%)) = 2,704 attempts × $21.36 | — | — |
| Gross direct cost avoidance | $86,518 | $28,754 + $57,764 | — | — |
| SafeBreak devices used assumption + Separation Rate | 8,359 | Projected IV Catheter assumption + 6,989 × 1.196 | — | — |
| Assumed SafeBreak device cost | $4.90 | Device cost assumption | — | — |
| Estimated device investment | $40,959 | 8,359 × $4.90 | — | — |
SafeBreak Registry Clinical Report - DEMO 2
ALL HOSPITAL DATA
Enrolled
575
Average Complication Reduction
87.6%
Estimated Savings per Hospital
$786K
Average Complication Rate
5.0%
ALL HOSPITAL DATA Key Summary
- 9 of the 10 separations were infusing medication at time of separation with only 2 (20%) needing IV restart
- 80% of events did not need product or supply changes
- SafeBreak saved on average 17.5 minutes for time to replace a SafeBreak vs time to restart IV
- Nurse overall satisfaction score was 9.6 out of 10
Clinical Outcomes
Financial Outcomes
Operational Outcomes
SafeBreak® Vascular Registry
A Breakaway Device for All Vascular Access Lines
Please select the form section that matches the data you need to enter. Registration information only needs to be completed once for each patient. Event information should be completed when a SafeBreak® separation and/or vascular access complication occurs.