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Team VOD
Vaso-Occlusion Detection
        Matthew Plaisance
        Madison McLeod
         Francois Decuir
         Uttam Dhodary
Summary

• Vaso-occlusion, which is the obstruction of
  blood flow in a vessel, leads to ischemia,
  chronic pain, and, if left untreated, tissue
  death (Yale et. al. 1349-1356)

• Caregivers are routinely unable to correlate the
  magnitude of a vaso-occlusive event and pain
  in patients with sickle cell disease.
Summary


The subjective pain scale is the primary method of
detection
  • Patient ranks his/her pain on a scale of 1-10
  • Contains no biometric data that relates severity of
    vaso-occlusion to pain
Summary

• Purpose: develop a modified pulse oximeter that
  will measure oxygen saturation or perfusion
  levels in tissue.
• Goal: determine a correlation between the
  oxygen levels and/or perfusion within the region
  of pain and the level of pain the patient is
  experiencing
• The device will, hopefully, lead to more efficient
  treatment
Sickle Cell Disease

• Malformation of hemoglobin
• Results in sickle-shaped red blood cells with
  altered function and lifespan
• Complications include painful vaso-occlusive
  episodes, ACS, stroke, pulmonary
  hypertension, multi-organ damage, decreased
  life-span (Conran 1-2)
• Affects 70,000-100,000 individuals in the US
  (SCDAA.com)
Vaso-Occlusion

• Most common complication of sickle cell
  disease

• Painful

• Can occur in arms, legs, chest, abdomen
  (American Family Physician 1027)
Vaso-Occlusion


• Sickled cells cannot
  deform to pass
  through small vessels

• Endothelial wall
  damage(Conran 4-8)
Pain

• Caused by infection and/or ischemia
• Pain occurs in legs, arms, lower back, knees,
  chest, abdomen
• 5% of patients with sickle cell disease have 3-10
  pain episodes per year
• Pain crises are the primary reason for ER visits
Pain Management

Drug Therapy
•    Mild Pain : NSAIDs
        (acetaminophen, aspirin, ibuprofen, naproxen)


•    Moderate-Severe Pain: Opioids
Pain Management
Common Opioids Used to Treat Mild to Moderate Pain in Sickle Cell Disease

  Drug                                                   Usual oral starting dosage in adults                      Comments and precautions
  Codeine                                                30 to 60 mg Every 3 or 4 hours                            Available in liquid or tablet form,
                                                                                                                   alone or in combination with
                                                                                                                   acetaminophen
                                                                                                                   Side effects: impaired ventilation
                                                                                                                   (histamine release possibly
                                                                                                                   triggering bronchospasm) and
                                                                                                                   increased intracranial pressure
                                                                                                                   as a result of carbon dioxide
                                                                                                                   retention
  Oxycodone (Roxicodone)                                 10 to 30 mg every 4 hours                                 Often used in combination with
                                                                                                                   acetaminophen, which limits
                                                                                                                   safe dosage to 12 tablets per day
                                                                                                                   (about 4 g of acetaminophen)

                                                                                                                   Side effects: similar to those of
                                                                                                                   codeine



    IM = intramuscular; IV = intravenous; SC = subcutaneous.
    *—Single-dose studies determined that the relative potency is 6:1; with repetitive doses, this ratio changes to 3:1.
Pain Management

                                                        Equianalgesic dosages                                     Usual starting dosage in adults
Drug                       Oral/IM potency              IM                           Oral                         Oral              Parenteral
Morphine                   6*                           10 mg                        60 mg                        15 to 30 mg every 0.1 to 0.15 mg per
(Duramorph)                                                                                                       4 hours           kg every 3 or 4
                                                                                                                                    hours

Hydromorphone              5                            1.5 mg                       7.5 mg                       2 to 4 mg every 4   1 to 2 mg every 4
(Dilaudid-Hp)                                                                                                     to 6 hours          to 6 hours


Meperidine                 4                            75 mg                        300 mg                       50 to 150 mg       75 to 100 mg
(Demerol)                                                                                                         every 3 or 4 hours every 3 or 4 hours


Levorphanol     2                                       2 mg                         4 mg                         2 to 4 mg every 6   Up to 1 mg IV
(Levo-Dromoran)                                                                                                   to 8 hours          every 3 to 6 hours;
                                                                                                                                      1 to 2 mg IM or SC
                                                                                                                                      every 6 to 8 hours


  IM = intramuscular; IV = intravenous; SC = subcutaneous.
  *—Single-dose studies determined that the relative potency is 6:1; with repetitive doses, this ratio changes to 3:1.
Reluctance of Pain
                        Treatment
•   Narcotic addiction & tolerance
•   Excessive sedation
•   Respiratory depression
•   ‘Drug-seeking’ behavior



• Addiction in sickle cell patients = ~3% (Yale et. al)
Pain Validation

• Pain scale—subjective

• CT*
• Chest X-Ray*
    *Not ordered regularly—very expensive


Need: A reliable, non-invasive, and inexpensive device
to provide correlating data between the occurance and
severity of vaso-occlusion and the pain that the patient
is experiencing
Specifications

• Vaso-occlusion reduces the flow of oxygenated
  blood, which leads to a reduction of oxygen within
  the tissue.

• Reduced oxygenation leads to tissue damage and
  pain.

• The device proposed will adapt the principles of
  photoplethysmography to measure the oxygen
  saturation level at the site of pain.
Specifications
Product Specification                                   Design Specification
                                                      Pulse oximetry will be used to detect the varying levels of
1.   Detecting varying levels of blood oxygen
                                                      blood oxygen saturation. This must be able to read blood
     saturation
                                                      oxygen saturation between 70% and 100% (ISO).
                                                      The device will be able to detect a fraction of the light that
2.    The device must be able to obtain               is originally emitted into the arm. The fraction will be
      measurements through 5 inches of flesh          determined using Beer’s Law and the optical properties of
                                                      human tissue.
                                                      No exposed wires will be present in the device, and the
3.     Electrical components must be isolated
                                                      leakage current will meet IEC standards (under 300µA).
                                                      This includes the time taken to attach the device to the
                                                      patient, the time required for the device to take
4.     Data acquisition must take less than 5 minutes
                                                      measurements, and the time for the device to interpret
                                                      the measurements taken
                                                      This device must be reliable with no false negatives. This
5.     Reliability
                                                      will follow ISO Standard 80601-2-61-2011.
                                                      The device should not cause any discomfort during use. It
6.     Comfort/Ease of Use                            should be easy to place on the patient and should be
                                                      easily removed
Alternative Methods
          Method             Specifications Met                     Pros                                           Cons



                                                                Non-invasive                 May be time consuming to find the exact
                                                                                             location of the vaso-occlusion
       Pulse Oximetry               All                         inexpensive
                                                                                             If the occlusion is too great, a signal may not be
                                                         easily adaptable for our use        determined



                                                                Non-invasive
                                    All                                                      May be time consuming to find the exact
       Perfusion Index                                                                       location of the vaso-occlusion
                                                                inexpensive

                                                                                             Expensive (Camera > $5002)
                                                                Non-invasive
        Fast Frame
                                    1,3
      “SpO2 Camera”1                                                                         Only measures O2 at surface



                                                                Non-invasive                 Expensive (Camera>$10003)

                                                  Gives a general view of temperature in the Only measures temperature at surface
          Thermal Imaging           1,3
                                                                     body
                                                                                             Can only work if vaso-occlusion causes a
                                                            Fast data acquisition            temperature difference in skin


Sources: 1(Kamshillin 996-1006); 2EdmundOptics.com; 3Neo-Bits.com
Method Chosen



• Modified Pulse Oximeter
  • Meets all specifications
  • Low Cost
Further Research

Further research is needed in the following areas:
• Pathology of vaso-occlusion
• Location of vaso-occlusion
• Frequency of vaso-occlusion
• Size of affected area
• Time in which ischemia occurs
• Treatments for vaso-occlusion
     (not pain treatment)
Specific Aims
1. Confirm that a Vaso-Occlusive Crisis Can be
   Detected

  – Blood Oxygen Saturation

  – Pulse Oximetry

  – Photoplethysmography
Specific Aims
2. Develop a Device that Can Measure the
   Varying Oxygenation Levels
   – The device will be developed using various
     programming software and hardware
        –LabView
        –LEDs
        –Photodetector
Specific Aims
3. Design the Device so that it can be Attached
   to a Patient’s Arm of Varying Sizes
   – This device should be able to adjust to
     varying thicknesses.
         –Adjustable armband
Specific Aims
4. Find a Correlation Between Oxygen
   Saturation in the Blood and Pain

  – A pain scale can be created that ranges
    from one to ten.

  – Each number on the pain scale can correlate
    to a specific range of oxygen saturation
    levels.
Preliminary Results




 (Figure 1adopted from Ahmed et. al.)
Preliminary Data
• Methods of Data Collection
  – Vaso-occlusive crisis was simulated
     • A tourniquet was used to do this

  – Different pulse oximeters were used
     • Nano Tracker
     • Medtronic Lifepak 12 Clinical Pulse Oximeter
     • AD Instruments MLT321 Pulse Oximeters
Preliminary Data
         Table 1 - DATA FROM PHOTOPLETHYSMOGRAPH (NANO TRACKER)


                    Normal O2      Normal O2    O2--V-O Mimic O2--V-O Mimic
                     Left Arm      Right Arm         Left         Right



Subject 1               n/a           0.93            n/a         0.74


Subject 2              0.95           0.97           0.76          0.8


Subject 3              0.97           0.97           0.78         0.82

STDV L    0.11030 STDV R 0.09786
         n=2
                                   p=0.0035 - Right Arm
                  n=3
                                   p=0.0055 - Left Arm
Preliminary Data

                  Table 2 - DATA FROM MEDTRONIC LIFEPAK 12 PULSE OX


                            Normal O2 Left O2--V-O Mimic
                                                               Perfusion Index
                                Arm             Left



Subject 1                         0.97          0.86       Decreased


Subject 2                         0.96          0.88       No Change

Subject 3                         0.98          0.88       Decreased

STDV         0.053821
                          p=0.0004
            n=3
Preliminary Data
                        Table 3 - DATA FROM AD INSTRUMENTS PULSE OX

                                          O2 Experimental
                            Normal O2
                                               Arm
                                                                O2--Experimental
                                              (Normal
                           Control Arm
                                             Conditions)
Subject 1                      0.97             0.97                     0.92
Subject 2                      0.95             0.96                     0.91
Subject 3                     0.974            0.983                  0.953
Subject 4                      0.99             0.99                     0.96
                         p=0.0540—Control vs. Experimental
STDV Exp     0.028116
                         p=0.0285—Experimental (Normal Conditions) vs.
            n=4
                                   Experimental Conditions
Preliminary Data
• T-test Values
   – Table 1
       • p=0.0035 - Right Arm
       • p=0.0055 - Left Arm
   – Table 2
       • p = 0.0004
   – Table 3
       • p = 0.054 – Control vs. Experimental
       • p = 0.0285 – Experimental (Normal Conditions) vs.
                           Experimental Conditions
Purpose
• Detect Low oxygen concentration in
  extremities.
• Easy and cheap diagnostic technique for vaso-
  occlusion patient.
• Early diagnosis ease the treatment and
  prevent further damage.
Working Principle
• Pulse Oxymetry consist of Red(R) and
  infra red (IR) light emitting LEDs and a
  photo detector/s.
• Oxygenated and de-oxygenated
  hemoglobin have differential light
  absorption rate.
   – Oxygenated hemoglobin absorbs more
     infrared light and deoxygenated
     hemoglobin absorbs more red light.
• Photo detector measures the
  transmitted lights and calculate R/IR
  ratio.
• R/IR ratio determines the oxygen blood
  concentration.
Modification

• The pulse Oxymetry will be modified to fit in
the extremities.
• High power LEDs will be used for larger parts.
• Two oximeters will be used for control and
experimental data.
• Multi-array detector will be used if needed
Proposed Solution
• Single source multiple detector can be
used.
• Uneven distribution on the detector can
be analyzed mathematically.
• The output in the detector can be
averaged out to find the occlusion.
• Non-linear transmission of the light can
result the uniform result.
• Experiment can be conducted to test the
linear behavior of the device.
Proposed Solution

• Rotating LEDs with aligned
detectors can be designed.
• Signal from detector can be
reconstructed using convolution.
• Complicated design but it can
be promising solution.
• CT scan uses same mechanism
to create the cross sectional area.
Cost Structure
                    Per Unit     Price in    Number of       Number of     Total      Our Cost
  Components
                    Price ($)    bulk($)    pieces in Bulk   units used   Price ($)     ($)

    Op Amp            0.92                                      12         11.04       11.04
   Resistors          0.05        2.33           50            20-40       13.98       13.98
   Capacitor          0.12        2.9            25             4-8        29.00       29.00
  LED 660/940         4.64                                       5         25.00       25.00
  Bread Board        18.00                                       1         18.00       18.00
   ArmBand           60.00                                       1         60.00       60.00
 Photodetector       44.00                                       5        220.00      220.00
Analog to Digital
                    280.00                                       1        280.00      Donated
   Converter
Computer with
                                                                          3200.00     Donated
  Software
     Travel                                                               150.00      150.00
                                             Total Price                  4007.00       527.02
Testing
• The device has to be calibrated for each
individual.
• The device uses its data and compares with
the control data.
• Device will correlate the severity of the vaso-
occlusion measuring the blood oxygen
concentration.
Design Specification

• Our device
will utilize an
adjustable arm-
band design.
• We will use
multiple LEDs
and detectors
Benefits of a Multiple LED system

• Produces more light which allows
  detector to see dark spots better

• Even if the crisis occurs outside of the
  emitance of the LED, our detectors can
  identify a crisis
Technique

• We will use two pulse oximeters
• This can allow us to get a
  baseline reading while
  simultaneously attempting to
  identify a crisis
• Preliminary testing has proven
  this method to be viable
Recreating a vaso-occlusion

• Vaso-occlusion causes less blood to
  reach tissue

• We were able to slow blood flow to
  the extremities using a
  sphygmomanometer
Pain scale

Numbers from device          Pain Scale

       <0.82                   9-10

      .82-.86                   6-8

      .86-.90                   4-5

        .90                     1-3
Ghantt Chart
References
•   Ahmed, Shahid, Anita K. Siddiqui, Cristina P. Sison, Rabia K. Shahid, and Joseph Mattana. "Hemoglobin Oxygen Saturation Discrepancy Using
    Various Methods in Patients with Sickle Cell Vaso-occlusive Painful Crisis." European Journal of Haematology 74.4 (2005): 309-14. Print.
•
•   Ashley Koch, Yang Q, and Olney R.S. "American Journal of EPIDEMIOLOGY." Humane Genome Epidemiology Review. Sickle Hemoglobin (Hb
    S) Allele and Sickle Cell Disease: A Huge Review. John Hopkins Hospital, 9 May 2000. Web. 18 Oct. 2012.

•   Bishop, Charles W., MD, Phyllis E. Bowen, Ph. D., and S. J. Ritchey, Ph. D. "Norms for Nutritional Assessment of American Adults by Upper Arm
    Anthropometry." American Journal of Clinical Nutrition 34 (1981): 2530-539. Web.
•
•   Conran, Nicola, Carla Franco-Penteado, and Fernando Costa. "Newer Aspects of the Pathophysiology of Sickle Cell Disease Vaso-
    Occlusion." Hemoglobin 33.1 (2009): 1-16. Print.
•
•   "CT Scan vs MRI." - Difference and Comparison. N.p., n.d. Web. 24 Oct. 2012. <http://www.diffen.com/difference/CT_Scan_vs_MRI>.

•   "Edmund Optics: USB 2.0 CMOS Machine Vision Cameras." Optics, Imaging, and Photonics Technology. Edmund Optics, n.d. Web. 23 Oct. 2012.
    <http://www.edmundoptics.com/imaging/cameras/usb-cameras/eo-usb-2-0-cmos-machine-vision-cameras/2818>.
•
•   Eker, Charlotta. Optical Characterization of Tissue for Medical Diagnostics. Lund: n.p., 1999. Web.
    <http://www.atomic.physics.lu.se/fileadmin/atomfysik/Biophotonics/PhD_Theses/PhD_Thesis_Charlotta_Eker.pdf>.

•   "FLIR I3 Compact Thermal Imaging IR Camera." FLIR Systems. NeoBits, n.d. Web. 23 Oct. 2012.
    <http://www.neobits.com/flir_systems_60101_0101_60101_0101_flir_i3_compact_p3946969.html?atc=gbs>.
•
•   Hay Willian, Katsuyuki Miyasaka, and Christian Poets. "Pulse Oxymetry Principle." Principle of Pulse Oximetry Technology. Ed. Steven Baker.
    Masimo Corporation, Siemens, 10 Sept. 2010. Web. 18 Oct. 2012.
References
•   "How Does a Pulse Oximeter Work." Http://portableoxygenconcentrator.com. POCmedical, n.d. Web. 24 Oct. 2012. <http://www.google.com/imgres?start=944>.

•   Ignjatovic Nebojsa, Marina Vasiljevic, Dragan Milic, Jelena Stefanovic, Miroslav Stojanovic, Aleksandar Karanikolic, Alenksandar Zlatic, Goran Djordjevic, Sasa
    Zivic, Ljiljana Jeremic, Ivona Djordjevic, and Radmilo Jankovic. "Diagnostic Importance of Pulse Oximetry in the Determination of the Stage of Chronic Arterial
    Insufficiency of Lower Extremities." Diagnostic Importance of Pulse Oximetry in the Determination of the Stage of Chronic Arterial Insufficiency of Lower
    Extremities (2010): 300-04. Doiserbia.nb.rs. May-June 2010. Web. 18 Oct. 2012.

•   Julian L. Allen, et al. "Hypoxaemia In Sickle Cell Disease: Biomarker Modulation And Relevance To Pathophysiology." Lancet 362.9394 (2003): 1450-1455.
    Academic Search Complete. Web. 21 Oct. 2012.
•
•   Kamshilin, Alexei A., Serguei Miridonov, Victor Teplov, Riku Saarenheimo, and Ervin Nippolainen. "Photoplethysmographic Imaging of High Spatial
    Resolution."Biomedical Optics Express 2.4 (2011): 996-1006. Web.
•
•   Lonergan Gael J., David B. Cline, and Susan L. Abbondanzo. "Sickle Cell Anemia." RadioGraphics. N.p., n.d. Web. 18 Oct. 2012.
    <http://radiographics.rsna.org/content/21/4/971.full>.

•   Lopez, Bernard L., et al. "Pulse Oximetry in the Adult ED Patient with Sickle Cell." The American Journal of Emergency Medicine 23.4 (2005): 429-32. ProQuest
    Nursing & Allied Health Source. 21 Oct. 2012 .
•
•   Particular Requirements for Basic Safety and Essential Performance of Pulse Oximetry Equipment. ISO 80601-2-61:2011. Geneva, Switzerland : ISO.
•
•   "Research & Screening." Sickle Cell Disease Association of America, Inc. Sickle Cell Disease Association of America, Inc., n.d. Web.
•
•   Schutz, Sandra L. "Oxygen Saturation Monitoring by Pulse Oximetry." American Association of Critical-         Care Nurses. N.p., n.d. Web. 23 Oct. 2012.
    <http://www.aacn.org/WD/Practice/Docs/ch_14_PO.pdf>.

•   "Sickle Cell Disease." American Family Physician 62.5 (2000): 1027-028. Web.

•   "Sickle Cell Diseases." Genetic And Newborn Screening. Illinois Department of Public Health, n.d. Web. 18 Oct. 2012.

•   Yale, Steven H., MD, Nahed Nagib, MD, and Troy Guthrie, MD. "Approach to the Vaso-Occlusive Crisis in Adults with Sickle Cell Disease." American Family
    Physician61.5 (2000): 1349-356. Web.

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Vaso-occlusion Detection

  • 1. Team VOD Vaso-Occlusion Detection Matthew Plaisance Madison McLeod Francois Decuir Uttam Dhodary
  • 2. Summary • Vaso-occlusion, which is the obstruction of blood flow in a vessel, leads to ischemia, chronic pain, and, if left untreated, tissue death (Yale et. al. 1349-1356) • Caregivers are routinely unable to correlate the magnitude of a vaso-occlusive event and pain in patients with sickle cell disease.
  • 3. Summary The subjective pain scale is the primary method of detection • Patient ranks his/her pain on a scale of 1-10 • Contains no biometric data that relates severity of vaso-occlusion to pain
  • 4. Summary • Purpose: develop a modified pulse oximeter that will measure oxygen saturation or perfusion levels in tissue. • Goal: determine a correlation between the oxygen levels and/or perfusion within the region of pain and the level of pain the patient is experiencing • The device will, hopefully, lead to more efficient treatment
  • 5. Sickle Cell Disease • Malformation of hemoglobin • Results in sickle-shaped red blood cells with altered function and lifespan • Complications include painful vaso-occlusive episodes, ACS, stroke, pulmonary hypertension, multi-organ damage, decreased life-span (Conran 1-2) • Affects 70,000-100,000 individuals in the US (SCDAA.com)
  • 6. Vaso-Occlusion • Most common complication of sickle cell disease • Painful • Can occur in arms, legs, chest, abdomen (American Family Physician 1027)
  • 7. Vaso-Occlusion • Sickled cells cannot deform to pass through small vessels • Endothelial wall damage(Conran 4-8)
  • 8. Pain • Caused by infection and/or ischemia • Pain occurs in legs, arms, lower back, knees, chest, abdomen • 5% of patients with sickle cell disease have 3-10 pain episodes per year • Pain crises are the primary reason for ER visits
  • 9. Pain Management Drug Therapy • Mild Pain : NSAIDs (acetaminophen, aspirin, ibuprofen, naproxen) • Moderate-Severe Pain: Opioids
  • 10. Pain Management Common Opioids Used to Treat Mild to Moderate Pain in Sickle Cell Disease Drug Usual oral starting dosage in adults Comments and precautions Codeine 30 to 60 mg Every 3 or 4 hours Available in liquid or tablet form, alone or in combination with acetaminophen Side effects: impaired ventilation (histamine release possibly triggering bronchospasm) and increased intracranial pressure as a result of carbon dioxide retention Oxycodone (Roxicodone) 10 to 30 mg every 4 hours Often used in combination with acetaminophen, which limits safe dosage to 12 tablets per day (about 4 g of acetaminophen) Side effects: similar to those of codeine IM = intramuscular; IV = intravenous; SC = subcutaneous. *—Single-dose studies determined that the relative potency is 6:1; with repetitive doses, this ratio changes to 3:1.
  • 11. Pain Management Equianalgesic dosages Usual starting dosage in adults Drug Oral/IM potency IM Oral Oral Parenteral Morphine 6* 10 mg 60 mg 15 to 30 mg every 0.1 to 0.15 mg per (Duramorph) 4 hours kg every 3 or 4 hours Hydromorphone 5 1.5 mg 7.5 mg 2 to 4 mg every 4 1 to 2 mg every 4 (Dilaudid-Hp) to 6 hours to 6 hours Meperidine 4 75 mg 300 mg 50 to 150 mg 75 to 100 mg (Demerol) every 3 or 4 hours every 3 or 4 hours Levorphanol 2 2 mg 4 mg 2 to 4 mg every 6 Up to 1 mg IV (Levo-Dromoran) to 8 hours every 3 to 6 hours; 1 to 2 mg IM or SC every 6 to 8 hours IM = intramuscular; IV = intravenous; SC = subcutaneous. *—Single-dose studies determined that the relative potency is 6:1; with repetitive doses, this ratio changes to 3:1.
  • 12. Reluctance of Pain Treatment • Narcotic addiction & tolerance • Excessive sedation • Respiratory depression • ‘Drug-seeking’ behavior • Addiction in sickle cell patients = ~3% (Yale et. al)
  • 13. Pain Validation • Pain scale—subjective • CT* • Chest X-Ray* *Not ordered regularly—very expensive Need: A reliable, non-invasive, and inexpensive device to provide correlating data between the occurance and severity of vaso-occlusion and the pain that the patient is experiencing
  • 14. Specifications • Vaso-occlusion reduces the flow of oxygenated blood, which leads to a reduction of oxygen within the tissue. • Reduced oxygenation leads to tissue damage and pain. • The device proposed will adapt the principles of photoplethysmography to measure the oxygen saturation level at the site of pain.
  • 15. Specifications Product Specification Design Specification Pulse oximetry will be used to detect the varying levels of 1. Detecting varying levels of blood oxygen blood oxygen saturation. This must be able to read blood saturation oxygen saturation between 70% and 100% (ISO). The device will be able to detect a fraction of the light that 2. The device must be able to obtain is originally emitted into the arm. The fraction will be measurements through 5 inches of flesh determined using Beer’s Law and the optical properties of human tissue. No exposed wires will be present in the device, and the 3. Electrical components must be isolated leakage current will meet IEC standards (under 300µA). This includes the time taken to attach the device to the patient, the time required for the device to take 4. Data acquisition must take less than 5 minutes measurements, and the time for the device to interpret the measurements taken This device must be reliable with no false negatives. This 5. Reliability will follow ISO Standard 80601-2-61-2011. The device should not cause any discomfort during use. It 6. Comfort/Ease of Use should be easy to place on the patient and should be easily removed
  • 16. Alternative Methods Method Specifications Met Pros Cons Non-invasive May be time consuming to find the exact location of the vaso-occlusion Pulse Oximetry All inexpensive If the occlusion is too great, a signal may not be easily adaptable for our use determined Non-invasive All May be time consuming to find the exact Perfusion Index location of the vaso-occlusion inexpensive Expensive (Camera > $5002) Non-invasive Fast Frame 1,3 “SpO2 Camera”1 Only measures O2 at surface Non-invasive Expensive (Camera>$10003) Gives a general view of temperature in the Only measures temperature at surface Thermal Imaging 1,3 body Can only work if vaso-occlusion causes a Fast data acquisition temperature difference in skin Sources: 1(Kamshillin 996-1006); 2EdmundOptics.com; 3Neo-Bits.com
  • 17. Method Chosen • Modified Pulse Oximeter • Meets all specifications • Low Cost
  • 18. Further Research Further research is needed in the following areas: • Pathology of vaso-occlusion • Location of vaso-occlusion • Frequency of vaso-occlusion • Size of affected area • Time in which ischemia occurs • Treatments for vaso-occlusion (not pain treatment)
  • 19. Specific Aims 1. Confirm that a Vaso-Occlusive Crisis Can be Detected – Blood Oxygen Saturation – Pulse Oximetry – Photoplethysmography
  • 20. Specific Aims 2. Develop a Device that Can Measure the Varying Oxygenation Levels – The device will be developed using various programming software and hardware –LabView –LEDs –Photodetector
  • 21. Specific Aims 3. Design the Device so that it can be Attached to a Patient’s Arm of Varying Sizes – This device should be able to adjust to varying thicknesses. –Adjustable armband
  • 22. Specific Aims 4. Find a Correlation Between Oxygen Saturation in the Blood and Pain – A pain scale can be created that ranges from one to ten. – Each number on the pain scale can correlate to a specific range of oxygen saturation levels.
  • 23. Preliminary Results (Figure 1adopted from Ahmed et. al.)
  • 24. Preliminary Data • Methods of Data Collection – Vaso-occlusive crisis was simulated • A tourniquet was used to do this – Different pulse oximeters were used • Nano Tracker • Medtronic Lifepak 12 Clinical Pulse Oximeter • AD Instruments MLT321 Pulse Oximeters
  • 25. Preliminary Data Table 1 - DATA FROM PHOTOPLETHYSMOGRAPH (NANO TRACKER) Normal O2 Normal O2 O2--V-O Mimic O2--V-O Mimic Left Arm Right Arm Left Right Subject 1 n/a 0.93 n/a 0.74 Subject 2 0.95 0.97 0.76 0.8 Subject 3 0.97 0.97 0.78 0.82 STDV L 0.11030 STDV R 0.09786 n=2 p=0.0035 - Right Arm n=3 p=0.0055 - Left Arm
  • 26. Preliminary Data Table 2 - DATA FROM MEDTRONIC LIFEPAK 12 PULSE OX Normal O2 Left O2--V-O Mimic Perfusion Index Arm Left Subject 1 0.97 0.86 Decreased Subject 2 0.96 0.88 No Change Subject 3 0.98 0.88 Decreased STDV 0.053821 p=0.0004 n=3
  • 27. Preliminary Data Table 3 - DATA FROM AD INSTRUMENTS PULSE OX O2 Experimental Normal O2 Arm O2--Experimental (Normal Control Arm Conditions) Subject 1 0.97 0.97 0.92 Subject 2 0.95 0.96 0.91 Subject 3 0.974 0.983 0.953 Subject 4 0.99 0.99 0.96 p=0.0540—Control vs. Experimental STDV Exp 0.028116 p=0.0285—Experimental (Normal Conditions) vs. n=4 Experimental Conditions
  • 28. Preliminary Data • T-test Values – Table 1 • p=0.0035 - Right Arm • p=0.0055 - Left Arm – Table 2 • p = 0.0004 – Table 3 • p = 0.054 – Control vs. Experimental • p = 0.0285 – Experimental (Normal Conditions) vs. Experimental Conditions
  • 29. Purpose • Detect Low oxygen concentration in extremities. • Easy and cheap diagnostic technique for vaso- occlusion patient. • Early diagnosis ease the treatment and prevent further damage.
  • 30. Working Principle • Pulse Oxymetry consist of Red(R) and infra red (IR) light emitting LEDs and a photo detector/s. • Oxygenated and de-oxygenated hemoglobin have differential light absorption rate. – Oxygenated hemoglobin absorbs more infrared light and deoxygenated hemoglobin absorbs more red light. • Photo detector measures the transmitted lights and calculate R/IR ratio. • R/IR ratio determines the oxygen blood concentration.
  • 31. Modification • The pulse Oxymetry will be modified to fit in the extremities. • High power LEDs will be used for larger parts. • Two oximeters will be used for control and experimental data. • Multi-array detector will be used if needed
  • 32. Proposed Solution • Single source multiple detector can be used. • Uneven distribution on the detector can be analyzed mathematically. • The output in the detector can be averaged out to find the occlusion. • Non-linear transmission of the light can result the uniform result. • Experiment can be conducted to test the linear behavior of the device.
  • 33. Proposed Solution • Rotating LEDs with aligned detectors can be designed. • Signal from detector can be reconstructed using convolution. • Complicated design but it can be promising solution. • CT scan uses same mechanism to create the cross sectional area.
  • 34. Cost Structure Per Unit Price in Number of Number of Total Our Cost Components Price ($) bulk($) pieces in Bulk units used Price ($) ($) Op Amp 0.92 12 11.04 11.04 Resistors 0.05 2.33 50 20-40 13.98 13.98 Capacitor 0.12 2.9 25 4-8 29.00 29.00 LED 660/940 4.64 5 25.00 25.00 Bread Board 18.00 1 18.00 18.00 ArmBand 60.00 1 60.00 60.00 Photodetector 44.00 5 220.00 220.00 Analog to Digital 280.00 1 280.00 Donated Converter Computer with 3200.00 Donated Software Travel 150.00 150.00 Total Price 4007.00 527.02
  • 35. Testing • The device has to be calibrated for each individual. • The device uses its data and compares with the control data. • Device will correlate the severity of the vaso- occlusion measuring the blood oxygen concentration.
  • 36. Design Specification • Our device will utilize an adjustable arm- band design. • We will use multiple LEDs and detectors
  • 37. Benefits of a Multiple LED system • Produces more light which allows detector to see dark spots better • Even if the crisis occurs outside of the emitance of the LED, our detectors can identify a crisis
  • 38. Technique • We will use two pulse oximeters • This can allow us to get a baseline reading while simultaneously attempting to identify a crisis • Preliminary testing has proven this method to be viable
  • 39. Recreating a vaso-occlusion • Vaso-occlusion causes less blood to reach tissue • We were able to slow blood flow to the extremities using a sphygmomanometer
  • 40. Pain scale Numbers from device Pain Scale <0.82 9-10 .82-.86 6-8 .86-.90 4-5 .90 1-3
  • 42. References • Ahmed, Shahid, Anita K. Siddiqui, Cristina P. Sison, Rabia K. Shahid, and Joseph Mattana. "Hemoglobin Oxygen Saturation Discrepancy Using Various Methods in Patients with Sickle Cell Vaso-occlusive Painful Crisis." European Journal of Haematology 74.4 (2005): 309-14. Print. • • Ashley Koch, Yang Q, and Olney R.S. "American Journal of EPIDEMIOLOGY." Humane Genome Epidemiology Review. Sickle Hemoglobin (Hb S) Allele and Sickle Cell Disease: A Huge Review. John Hopkins Hospital, 9 May 2000. Web. 18 Oct. 2012. • Bishop, Charles W., MD, Phyllis E. Bowen, Ph. D., and S. J. Ritchey, Ph. D. "Norms for Nutritional Assessment of American Adults by Upper Arm Anthropometry." American Journal of Clinical Nutrition 34 (1981): 2530-539. Web. • • Conran, Nicola, Carla Franco-Penteado, and Fernando Costa. "Newer Aspects of the Pathophysiology of Sickle Cell Disease Vaso- Occlusion." Hemoglobin 33.1 (2009): 1-16. Print. • • "CT Scan vs MRI." - Difference and Comparison. N.p., n.d. Web. 24 Oct. 2012. <http://www.diffen.com/difference/CT_Scan_vs_MRI>. • "Edmund Optics: USB 2.0 CMOS Machine Vision Cameras." Optics, Imaging, and Photonics Technology. Edmund Optics, n.d. Web. 23 Oct. 2012. <http://www.edmundoptics.com/imaging/cameras/usb-cameras/eo-usb-2-0-cmos-machine-vision-cameras/2818>. • • Eker, Charlotta. Optical Characterization of Tissue for Medical Diagnostics. Lund: n.p., 1999. Web. <http://www.atomic.physics.lu.se/fileadmin/atomfysik/Biophotonics/PhD_Theses/PhD_Thesis_Charlotta_Eker.pdf>. • "FLIR I3 Compact Thermal Imaging IR Camera." FLIR Systems. NeoBits, n.d. Web. 23 Oct. 2012. <http://www.neobits.com/flir_systems_60101_0101_60101_0101_flir_i3_compact_p3946969.html?atc=gbs>. • • Hay Willian, Katsuyuki Miyasaka, and Christian Poets. "Pulse Oxymetry Principle." Principle of Pulse Oximetry Technology. Ed. Steven Baker. Masimo Corporation, Siemens, 10 Sept. 2010. Web. 18 Oct. 2012.
  • 43. References • "How Does a Pulse Oximeter Work." Http://portableoxygenconcentrator.com. POCmedical, n.d. Web. 24 Oct. 2012. <http://www.google.com/imgres?start=944>. • Ignjatovic Nebojsa, Marina Vasiljevic, Dragan Milic, Jelena Stefanovic, Miroslav Stojanovic, Aleksandar Karanikolic, Alenksandar Zlatic, Goran Djordjevic, Sasa Zivic, Ljiljana Jeremic, Ivona Djordjevic, and Radmilo Jankovic. "Diagnostic Importance of Pulse Oximetry in the Determination of the Stage of Chronic Arterial Insufficiency of Lower Extremities." Diagnostic Importance of Pulse Oximetry in the Determination of the Stage of Chronic Arterial Insufficiency of Lower Extremities (2010): 300-04. Doiserbia.nb.rs. May-June 2010. Web. 18 Oct. 2012. • Julian L. Allen, et al. "Hypoxaemia In Sickle Cell Disease: Biomarker Modulation And Relevance To Pathophysiology." Lancet 362.9394 (2003): 1450-1455. Academic Search Complete. Web. 21 Oct. 2012. • • Kamshilin, Alexei A., Serguei Miridonov, Victor Teplov, Riku Saarenheimo, and Ervin Nippolainen. "Photoplethysmographic Imaging of High Spatial Resolution."Biomedical Optics Express 2.4 (2011): 996-1006. Web. • • Lonergan Gael J., David B. Cline, and Susan L. Abbondanzo. "Sickle Cell Anemia." RadioGraphics. N.p., n.d. Web. 18 Oct. 2012. <http://radiographics.rsna.org/content/21/4/971.full>. • Lopez, Bernard L., et al. "Pulse Oximetry in the Adult ED Patient with Sickle Cell." The American Journal of Emergency Medicine 23.4 (2005): 429-32. ProQuest Nursing & Allied Health Source. 21 Oct. 2012 . • • Particular Requirements for Basic Safety and Essential Performance of Pulse Oximetry Equipment. ISO 80601-2-61:2011. Geneva, Switzerland : ISO. • • "Research & Screening." Sickle Cell Disease Association of America, Inc. Sickle Cell Disease Association of America, Inc., n.d. Web. • • Schutz, Sandra L. "Oxygen Saturation Monitoring by Pulse Oximetry." American Association of Critical- Care Nurses. N.p., n.d. Web. 23 Oct. 2012. <http://www.aacn.org/WD/Practice/Docs/ch_14_PO.pdf>. • "Sickle Cell Disease." American Family Physician 62.5 (2000): 1027-028. Web. • "Sickle Cell Diseases." Genetic And Newborn Screening. Illinois Department of Public Health, n.d. Web. 18 Oct. 2012. • Yale, Steven H., MD, Nahed Nagib, MD, and Troy Guthrie, MD. "Approach to the Vaso-Occlusive Crisis in Adults with Sickle Cell Disease." American Family Physician61.5 (2000): 1349-356. Web.

Notes de l'éditeur

  1. The varying levels of oxygen concentration in the blood can be used as an indicator to determine whether or not a vaso-occlusive crisis is occurring. By using different optics techniques, such as pulse oximetry or photoplethysmography, these levels of oxygen concentration can be measured.
  2. This device should be able to adjust to varying thicknesses.
  3. Find a Correlation Between the Varying Levels of Oxygen Saturation in the Blood and the Level of Pain that an Individual May be ExperiencingA pain scale can be created that ranges from one to ten. Each number on the pain scale can correlate to a specific range of oxygen saturation levels.
  4. Research shows that people diagnosed with sickle cell anemia share a similar hemoglobin-oxygenation curve as people without the disease (Figure 1).Therefore, the principles of pulse oximetry are applicable to people with sickle cell disease; the oxygen saturation measurements taken on a person with Sickle Cell Disease with a pulse oximeter should be accurate compared to people without the disease. Our group conducted three experiments mimicking a vaso-occlusive crisis to determine if oxygen saturation percentages differed during normal and vaso-occlusive conditions.
  5. Methods of Data Collection. Vaso-occlusive crises were simulated by using a tourniquet. Different pulse oximeters were used to obtain the blood oxygen saturation percentages. These were the nanotracker, the medtroniklifepak 12 clinical pulse oximeter, and the AD Instruments MLT321 Pulse oximeters.
  6. Table 1 shows the data collected from the photoplethysmograph otherwise known as the nanotracker. A vaso-occlusive crisis was simulated using a tourniquet; the nano tracker recorded the blood oxygen concentration during the simulation. The table shows that the standard deviation and the p values are very small. These were calculated using the built in Excel functions, and this shows that the data was significant.
  7. Table 2 shows the data collected from the Medtronic Lifepak 12 Pulse Oximeter. This test also used a tourniquet to mimica vaso-occlusive crisis. The standard deviation and the p-values were also small for this experiment.
  8. The third test was conducted in the same fashion as the first two, but we added a control measurement while using AD Instruments MLT321 pulse oximeters. A pulse oximeter was placed on each hand. A vaso-occlusive crisis was simulated in one arm (experimental), and the other arm remained in normal conditions (control). During the simulation, the pulse oximeters took blood oxygenation concentration readings.
  9. T-tests were done on the sets of data within the three tables. The p-values shown were calculated using the T-Test function in Microsoft Excel.The results of the t-tests show that the O2 saturation decreased significantly when the tourniquet was placed on the arm. Therefore, it can be deduced that a pulse oximeter can detect a vaso-occlusive crisis. The pulse oximeter on the control hand read normal blood oxygenation levels while the pulse oximeter on the experimental arm read significantly lower blood oxygenation levels. By these experiments, it can be determined that a pulse oximeter can be used to detect the general location of a vaso-occlusion.
  10. The table shown here shows an estimation for the total price of our budget. This includes the cost of producing the prototype and the cost for travel to perform immersions. Currently, there are no major competitors against our design. In some cases, a doctor can order a CT scan, which costs $1200 - $3200 (“CT Scan vs. MRI”).
  11. Our device will utilize an adjustable arm-band design. This will allow the device to conform to different sizes and allow for ease of use. A system of multiple LEDs and detectors will be used.
  12. The benefits of a multiple LED system is that it produces more light which allows the detector to see dark spots better. Even if the crisis occurs outside of the emitance of the LED, our detectors can identify a crisis
  13. We have developed a technique which will incorporate two pulse oximeters. This allows us to get a baseline reading while at the same time identifying a crisis. Preliminary testing has proven this method to be viable.
  14. Recreating a vaso-occlusive crisis was important part of our research. We were able to recreate a vaso-occlusive by using a blood pressure cuff to slow blood flow to the extremities.
  15. Here is a table of what our proposed pain scale will look like.
  16. These are the references used in our proposal.