4 24/7 Beat by beat blood pressure Heart rate: accurate as ECG VAST APPLICATIONS (EXAMPLES)REPLACEMENT OF ARTERIAL CATHETERSHOME DIALYSIS REQUIREDHeart rate: accurate as ECGNO ELECTRODES OR ADHESIVESNO WIRESNO DERMATITUSRespiration rateNO CHEST BANDSNO ELECTRODESINSPIRATORY EFFORTNO IRRITATION
5 CareTaker Physiological Monitor Extracts pulse signal from fingerAnalyzes (decomposes) pulse wave form into the five characteristic constituent pulsesTracks beat by beat blood pressureSystolic, Diastolic, Mean, Pulse pressureHeart rate as accurately as ECGRespiration rateDetects hemorrhaging before shock sets in
6 How does this pulse sensor work? What is the magic?
7 PULSEActual raw dataIf the arteries are flexible, all five constituent pulses can often be observed
8 PULSE44 year old maleWith flexible arteriesActual Raw data
9 Pulse Pressure Wave Form P2P1 is the ratio between the amplitude of the second systolic peak,P2 ( the first reflection), and P1, the primary systolic peak.P2P1 tracks systolic pressure.T13P1P2T13 is the time that elapses between the primary (first systolic peak) and the diastolic peak second reflection).T13 tracks the pulse pressure.The first reflection (~17% of the pulse energy) occurs near the renal artery at the aorta and the second occurs near the iliac artery bifurcation (~40%).Example of actual raw data of pulse shape obtained by CareTaker at the finger.
11 CARETAKER FOLLOWS ECG ALMOST PERFECTLY 21 year oldR = 0.998
12 65 year old man with right side bundle branch block NOTE POOR QUALITY OF ECG FOR HEART RATE DETERMINATION NOTE GOOD QUALITY OF CARETAKER SIGNALN (RED TRACE)
13 HRV Differences in inter-beat interval (heart rate variability, HRV) Large HRV is a sign of good healthLow HRV is associated with illness (deteriorates before symptoms)HRVEach point is a heart beat
14 cNIBP CONTINUOUS NONINVASIVE BLOOD PRESSURE (cNIBP) Necessary and required for home dialysis systemsOverall correlation of SYSTOLIC PRESSURES from 43 dialysis runs.Overall correlation of PULSE PRESSURES from 43 dialysis runs.NHLBI SBIR Phase I, Continuous BP Monitor for dialysis applications, 1R43HL A1
15 cNIBPTrends in brachial cuff systolic pressure (red squares) and P2P1 over a 2.25 hr dialysis session (patient 24). Detail inset displays inspiratory-based modulations.Trends in brachial cuff pulse pressure (red squares) and T13 over a 2.25 hr dialysis session (patient 24). Detail inset displays inspiratory-based modulations.NHLBI SBIR Phase I, Continuous BP Monitor for dialysis applications, 1R43HL A1
16 CARETAKER TRACKS CENTRAL BLOOD PRESSURE 65 year old manOverlap between CareTaker (red) and central catheter (black) for 90 second observation
17 All Results of Central Catheter Comparison with CareTaker 3,417 Heart Beats
21 CareTaker Tracks Hemorrhaging World’s First Hemorrhage monitor 16 tests in lower body negative pressure chamberAll showed strong dependence on T13 as a function of simulated hemorrhaging.15 of 16 showed no relationship of conventional cuff measured BP to hemorrhaging.T13 changes from a normal value of about 300 msec to about 200 msec for loss of one liter of blood.5001000150020002002202402602803000 mmHg-60 mmHg-45 mmHg-30 mmHg-15 mmHgT13 (milliseconds)Time (Seconds)PDA - T13Statistical comparison between 15 cuff measurements taken simultaneously with T13.Statistically, pulse pressure can measure hemorrhaging, but not in an individual measurement.ONR SBIR Phase II with options, N C0204, Anti-Terrorism-Consequence Management and Recovery
22 Statistical Results of 15 LBNP Tests Tests at University of British Columbia
23 LBNP Comparison Finometer and CareTaker Hemorrhaging (simulated)LBNP Comparison Finometer and CareTakerThe Finometer Pro at $40,000 a copyNote digital noiseNote higher resolution of CareTakerTest at USAISR, San Antonio
24 T13 - THE HEMORRHAGE PARAMETER T13 as tracked by CareTaker tracks T13 (red) and as by central catheter (black)
25 Detection of Occult Hemorrhage T13 is a parameter that tracks pulse pressurePulse pressure correlates with hemorrhagingT13 values for adults are about msecT13 changes during hemorrhaging and can be used as a monitor of hemorrhaging.
26 Applications to Combat Casualty Care Real time vital sign for casualties on groundDetects and monitors hemorrhagingWarns caregivers, via radio, of out of range vital signs (example: tachycardia)- TriageCould serve as continuous noninvasive blood pressure (cNIBP) input to algorithmic resuscitation systems in development by both the Army and Navy
27 Nocturnal Dip A potentially explosive health issue The next slides showDaytime hypertension may not be much of a problem even if untreatedNocturnal hypertension may be a big problem and needs to be treated immediatelyWhy is nocturnal BP dipping greater than 20% also a problem?Because kidneys, heart, and brain need higher blood pressure for perfusion to work
28 – Syst-Eur Placebo Cohort Conventional, 24-h, Daytime and Night-time SBP as Predictors of Cardiovascular Endpoints– Syst-Eur Placebo CohortSystolic blood pressure (mmHg)2-year incidence of cardiovascular endpoints0.200.160.120.080.040.0090110130150170190210230Night-time24-hDaytimeConventionalVery DangerousStaessen JA et al. JAMA 1999;282:539–46
29 Dolan et al. Hypertension 2005;46:1-6 5-YEAR RISK OF CARDIOVASCULAR DEATH Relation to Clinic and Ambulatory BP - The Dublin Outcome StudyNight time24-hourDaytimeClinicAdjusted for other covariatesN = 5292Dolan et al. Hypertension 2005;46:1-6
30 IDACO - Characteristics by categories of the night:day ratio of SBP (n = 7458)Nocturnal hypertension is not treated in USDipping classLimitsNumber of patientsWomen, %Age, yAH treatment , %Diabetes mellitus , %CV disorder , %extreme<0.80151344.2592279normal≥0.80 to <0.90375446.055197decreased≥0.90 to <1.00175447.4572589reverse≥1.0043742.6633712146% !Across the 4 groups, all characteristics were significantly different with the exception of the proportion of women. Reverse dippers were older, more patients with a history of DM or previous CVD. And importantly reverse dipperes were more often on AHT.
31 Tabs show parameter history Tab for continuous observation of T13Tab for observation of continuous blood pressure
32 Display for CareTaker Raw data of pulse Beat by beat blood pressure Individual pulse parametersReconstructed pulseVertical lines show P1, P2, and P3
33 LIKELY measurements available with CareTaker multi-parameter physiological system: Augmentation Index for arthrosclerosisSleep apnea monitor, screening/diagnosis deviceObstructive sleep apneaCentral sleep apneaCPAP efficacy monitorHemorrhagic shock monitor/predictorAortic aneurism detectorFatigue or stress indicatorCardiac output measurementCircadian clock trackerAdvanced warning for nocturnal hypoglycemiaPredictor of disease state before symptoms
34 Other Uses for CareTaker Safer Dialysis sessions, home dialysis machinesReplaces most arterial catheters (80 – 90%)Home uses for elderly and worried wellRemote monitoring, observation, dosage adjustment, self medication, arrhythmia detection and classificationHome use for recovery from surgeryCan send data to doctor rather than go to ERCareTaker has detected and located aortic aneurismsUnder evaluation (predicted & located 5 of 5 in tests)Leg amputees are vulnerable to abdominal aneurysms
35 CareTaker for MRI and fMRI Presently used in Six Countries 33 feet of Teflon tubing separate the CareTaker unit from the finger cuffBrachial artery better than finger because of signal losses in tubingCARETAKER IS THE ONLY cNIBP SYSTEM THAT WORKS IN AN MRI
36 Modified Early Warning System (MEWS now NEWS) Display windows show trends over hours or days of:Heart rate, breathing rate, blood pressure, SPO2, Core Temperature and possibly other parametersAll parameters transmitted via radio to serverNurses never have to touch the patientPatients need not be waked up during the nightNear immediate results of drug/treatment efficacyAllows dosage adjustment over short timesContinuous record of patient’s vital signsProvides triage plan for disasters using limited staff
37 MEWSThe MEWS, specifically five selected parameters, may be used as a rapid, simple triage method to identify medical patients in need of hospital admission and those at increased risk of inhospital death.Modified early warning score predicts the need for hospital admission and inhospital mortality(VC Burch, G Tarr, C Morroni, Emerg Med J 2008;25: oi: /emj )
38 Why CareTaker is Necessary Exponential decrease in per capita number of physicians over next 10 to 15 yearsExponential increase in per capita need for physicians over next 10 to 15 yearsSystem breaks down at without telemedicineWorld’s largest economies will transition to remote diagnosis, treatment, and monitoring
39 Telemedicine funding at VA - a huge opportunity for CareTaker Ischemia: 1 in 3 Viet Nam Vets (200K) due to Agent OrangeSleep apnea: High incidenceDiabetes: High incidenceMany vets live in rural areas not near hospitals5.5 M Vets already enrolled1400 points of service18,000 doctors
40 Sleep Studies and Long Surgeries Detroit Sleep Studies in Progress – continuous blood pressure of spinal cord injured patientsCooperative data sharing agreement with VACooper University – 8 exploratory surgeries for five to seven hours in studyComparison with arterial catheters, instrumentsNew method to determine arterial stiffness discovered – patent in preparationManuscript in preparation
41 Aortic Aneurysms and Sudden Cardiac Arrest Detected and located five of five aortic aneurysms – monitored before/ after surgeryCharacteristic signals disappeared after surgeryBlind study – University of VirginiaAll signals obtained from the handTested CareTaker to determine Pulselessness at Cleveland Clinic – PublishedApplications to sudden cardiac arrest warning system built into wrist watch
42 RheoencephalographyNeuro ICU for detection of vasospasms, now nearly undetectable, but often fatalTrials at NMRC (Walter Reed) for monitoring traumatic brain injury (TBI)Trials in neuro ICU of University of VirginiaRequires CareTaker and conventional EEG and trans cranial impedance (TCI)
43 MRI Use of CareTakerInstalled in about 40 MRIs and fMRIs around the world as the only available beat by beat blood pressure monitor.Primarily used to study psychological effects.Manuscripts being prepared.Use in Japan to study antihypertensive medicines and use during dialysis.
44 New Relationships Forming China: clinical trials at Beijing Union Hospital (highest rated hospital, #1) planned for June 2013Relations with Suning of China are progressing for remote home health care monitorONR: current funding $850K. Option to start 2012 for $990K, resuscitation, HRWatch developmentAnimal and human resuscitation trial at UTMB, algorithmic fluid resuscitation, waiting on contract
45 More New Relationships BioPac Systems: worldwide distributor of CareTaker for MRI use (not Japan). 35 soldUpcoming presentation to Telstra (Australia), possible 3700 bedsTrials in Tanzania for Dr. Ellegala for remote hospital care. Planned for 2012Medica Teknika: Japanese distributor of CareTaker about 30 units
46 FDA Trials for CareTaker University of Virginia in progress.Trial design approved by FDA. 60 cohorts.Actual arterial line comparisons for four hours each.Progress: 25% of data analyzed. All patients completed.FDA: approvals for 510k are normally completed within 90 daysPredicted approval – summer 2013
47 First US Market Penetration of CareTaker into Markets 7 million arterial catheters used annuallyAbout 0.2% cause blood borne infections or blood clotsAverage cost of treating blood born infection is $35,000 to $65,000CareTaker could eliminate about 85+% of invasive catheter useCost of CareTaker is about the cost of one catheter and the surgical insertion