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Heart Rate Monitoring Saves
Lives of Premature Infants:
Results of HeRO Clinical Study
Douglas E. Lake, PhD
Research Assoc...
Presentation Outline
• HeRO RCT PI: Randall Moorman,MD
– Supported by NIH and Medical Predictive
Science Corporation (MPSC...
Abnormal HRC in neonatal sepsis
• Decreased heart rate variability
• Repetitive decelerations
Normal HRC

Abnormal HRC
2004-2010 Randomized Clinical Trial:
HRC monitoring in VLBW NICU patients
3003 VLBW infants admitted to 9 NICUs
had HRC mo...
High Impact Beyond NICU
•
•
•
•

No new drugs / procedure
No invasive device
No alarm or mandatory action required
Takes d...
Predictive Monitoring at UVA
• Massive monitoring data collection infrastructure
– Every NICU heartbeat since 1999 (~50 gi...
Lessons Learned
• Translating academic research to health care
system difficult and lengthy process
– Ask right clinical q...
SIE and Predictive Monitoring
• Data collection / visualization
– EMR / clinical data / text mining
– Graphical User Inter...
SIE and Signal Processing
• Multiple signals
– Correlation / entrainment
– Pairwise and global

• Entropy estimation
• Mul...
Continuous Physiological Monitoring
System Benefits / Challenges
• Provides valuable diagnosis information
– Analyze trend...
Periodic Breathing and Vital
Sign Entrainment
Sepsis ?
Necrotizing enterocolitis (NEC) ?
SIDS?
Adults?
Recent Unexpected NICU death
•
•
•
•
•

Five week old infant born at gestational age 25
Stable in step-down unit
Sudden ac...
Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study
Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study
Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study
Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study
Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study
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Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study

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Transcript of "Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study"

  1. 1. Heart Rate Monitoring Saves Lives of Premature Infants: Results of HeRO Clinical Study Douglas E. Lake, PhD Research Associate Professor Cardiovascular Division and Statistics * University of Virginia dlake@virginia.edu * MPSC (www.heroscore.com) shareholder
  2. 2. Presentation Outline • HeRO RCT PI: Randall Moorman,MD – Supported by NIH and Medical Predictive Science Corporation (MPSC) – Translational research lessons from HeRO • • • • Potential systems engineering research Pretty pictures from ongoing projects Big Data => study rare events like SIDS Accurate entropy estimation (math stuff)
  3. 3. Abnormal HRC in neonatal sepsis • Decreased heart rate variability • Repetitive decelerations Normal HRC Abnormal HRC
  4. 4. 2004-2010 Randomized Clinical Trial: HRC monitoring in VLBW NICU patients 3003 VLBW infants admitted to 9 NICUs had HRC monitoring randomize HRC display Non-display 22 % relative reduction in mortality in HRC display group (8.1 % versus 10.2%, p = 0.04) Moorman et al, J Pediatrics, Dec 2011
  5. 5. High Impact Beyond NICU • • • • No new drugs / procedure No invasive device No alarm or mandatory action required Takes data already available and repackages into clinically useful display • Clinical benefit rigorously demonstrated • More clinical significance than published “statistical significance” • Pioneering FDA “approval” (Don’t ask!)
  6. 6. Predictive Monitoring at UVA • Massive monitoring data collection infrastructure – Every NICU heartbeat since 1999 (~50 gigabeats) – Neonatal Apnea GO grant (stimulus funding 2009) – BedMaster: 75 bed licences (~10GB per day) • Adult ICU: Predictive monitoring in patients with trauma (PreMPT): Coulter award • Pre-Rescue Anticipatory Monitoring (PRAM) – 300 beds funded by UVA hospital for implementation – >100GB a day • Collaboration w/ Columbia, UCSF, INOVA, … => even BIGGER data (~3000 beds)
  7. 7. Lessons Learned • Translating academic research to health care system difficult and lengthy process – Ask right clinical question – Keep asking yourself “So what?” • Collect lots and lots of data (then collect more) – Automate as much as possible – Massive storage required for waveform data – Electronic medical records / research not there yet • Objective end points (no arbitrary thresholds) • Don’t let big data paralyze progress • Prominent role for systems engineering!
  8. 8. SIE and Predictive Monitoring • Data collection / visualization – EMR / clinical data / text mining – Graphical User Interface – Rapid retrieval of archived waveforms – Human factors / alarm fatigue • Analytics (modern data mining) – Black box -> Grey Box – Meaningful objective functions (e.g. $) – Missing / noisy data
  9. 9. SIE and Signal Processing • Multiple signals – Correlation / entrainment – Pairwise and global • Entropy estimation • Multivariate probability density estimation – Kernel methods – Big Data mitigates curse of dimensionality • Unsupervised clustering of signals – Incredibly brilliant or stupid
  10. 10. Continuous Physiological Monitoring System Benefits / Challenges • Provides valuable diagnosis information – Analyze trends and detect abrupt changes, but … • Repeated dependent measures a pain – Robust estimates of covariance (sandwich estimate) – Bootstrap estimates of CI’s and P-values • Modern data mining (datamininglab.com) – Yet to be fully adapted to health care applications – Messy data sporadically available – Real-time implementation issues
  11. 11. Periodic Breathing and Vital Sign Entrainment Sepsis ? Necrotizing enterocolitis (NEC) ? SIDS? Adults?
  12. 12. Recent Unexpected NICU death • • • • • Five week old infant born at gestational age 25 Stable in step-down unit Sudden acute apnea=>code=>died 3 hours later Presumed but unconfirmed sepsis Monitor data reviewd 3 days later – Extreme periodic breathing > 12 hours prior to death – Periodic SPO2 and HR => extreme correlation – Largest change in HR-SPO2 (i.e. brady/desat) • Same phenomena seen in adults
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