1. Mike McEvoy, PhD, NRP, RN, CCRN Sr. Staff RN – Cardiothoracic Surgery Chair – Resuscitation Committee – Albany Med Ctr EMS Coordinator – Saratoga County, New York EMS Editor – Fire Engineering magazine Non-Invasive Safety and Wellness Technologies

2. Mike McEvoy - Books:

3. Disclosures I am on the speakers bureau for Masimo Corporation. I am the EMS editor for Fire Engineering magazine. I do not intend to discuss any unlabeled or unapproved uses of drugs or products. Slides at: www.mikemcevoy.com

4. Nurses Week 2012 – Albany Medical Center (NY)

5. How Good Are You? HR LOC BP Resps

6. Not As Good As You Might Think: 50% of physical assessments wrong Therapeutic interventions altered with invasive assessment 34 - 56% of the time: 1980 Del Guercio 1984 Eisenberg 1990 Bailey 1991 Steinberg 1994 Minoz 1998 Staudinger 2002 Jacka, etc, etc…

7. How Good Are Your Monitors? What monitors?

8. Pulse Oximetry Problems: Accuracy Motion & artifact Dyshemoglobins Perfusion

9. Oxygenation Pulse Oximetry

10. Oxygenation Pulse Oximetry

11. Model of Light Absorption At Measurement Site Without Motion AC AC Variable light absorption due pulsatile volume of arterial blood DC DC Constant light absorption due to non-pulsatile arterial blood. DC DC Constant light absorption due to venous blood. DC Constant light absorption due to tissue, bone,... Absorption Time

12. Model of Light Absorption At Measurement Site With Motion AC AC Variable light absorption due pulsatile volume of arterial blood DC DC Constant light absorption due to non-pulsatile arterial blood. AC Variable light absorption due to moving venous blood DC DC Constant light absorption due to venous blood. DC Constant light absorption due to tissue, bone... Time Absorption

13. Influence of Perfusion on Accuracy of Conventional Pulse Oximetry During Motion Good Perfusion (Conventional PO) SpaO 2 =98 SpvO 2 =88 SpO 2 =93 Poor Perfusion (Conventional PO) SpO 2 =74 SpaO 2 =98 SpvO 2 =50

14. Post Processor R & IR Digitized, Filtered & Normalized R/IR MEASUREMENT CONFIDENCE % Saturation Conventional Pulse Oximetry Algorithm 3 options during motion or low perfusion: 1. Freeze last good value 2. Lengthen averaging cycle 3. Zero out

15. Next Generation Pulse Oximetry

17. Masimo SET: Signal Extraction Technology SET “Parallel Engines” Masimo SET “Parallel Engines” R/IR (Conventional Pulse Oximetry) Confidence Based Arbitrator 0 50% 66% 97% 100%SpO2% Post Processor Digitized, Filtered & Normalized % Saturation SST TM Proprietary Algorithm 4 DST SET – 97% DST TM FST TM MEASUREMENT CONFIDENCE MEASUREMENT CONFIDENCE MEASUREMENT CONFIDENCE MEASUREMENT CONFIDENCE MEASUREMENT CONFIDENCE R & IR

18. A Solution for Patient Motion Discrete Saturation Transform (DST) 0 50% 66% 86% 97% 100% SpO% SpO 2 % Measure Through Motion Pulse Oximetry Separating - accurate SpO 2 Conventional Pulse Oximetry 0 50% 66% 86% 97% 100% SpO% SpO 2 % Averaging - inaccurate SpO 2 Variable Constant Variable Constant In the presence of motion, SET separates the venous and arterial saturation values resulting in accurate saturation readings (compared to conventional oximetry that averages the values to produce a reading)

19. Certainty…

20. Pulse Oximetry Problems:  Accuracy  Motion & artifact Dyshemoglobins Perfusion

21. Carbon Monoxide (CO) Gas: Colorless Odorless Tasteless Nonirritating Leading cause of poisoning deaths worldwide!

22. CO: The Leading Cause of Poisoning Deaths 30-50 % of CO-exposed patients presenting to Emergency Departments are misdiagnosed Barker MD, et al. J Pediatr. 1988;1:233-43 Barret L, et al. Clin Toxicol. 1985;23:309-13 Grace TW, et al. JAMA. 1981;246:1698-700

23. Show me the money…Is this real?  104 CCU admissions UAP: 3 CO toxic, 5 others minor exposure (> smoker). Balzan et al, Postgrad Med J, 1994;70:699-702  307 acute neuro admits: 3 CO toxic (all from group of 29 w/ decr. LOC absent focal s/s). Balzan et al, Postgrad Med J, 1996;72:470-3.  168 acute neuro admits: 5 CO toxic (2 from group w/ seizures) Heckerling et al, Clin Toxicol, 1990;28:29-44.  48 h/a pts: 7 COHb > 10% (14.6%, all unrelated to smoking) Heckerling et al, Am J Emer Med, 1987;5:201-4.  146 h/a pts: 4 COHb > 10% (3%, all unrelated to smoking) Heckerling et al, Ann Intern Med, 1987;107:174-6. Up to 10% of UAP, ACS, seizure, and h/a admits have CO poisoning

24. Limitations of Pulse Oximetry Barker SJ, Tremper KK. The Effect of Carbon Monoxide Inhalation on Pulse Oximetry and Transcutaneous PO 2. Anesthesiology 1987; 66:677-679 SpCO-SpO 2 Gap: The fractional difference between actual SaO 2 and display of SpO 2 (2 wavelength oximetry) in presence of carboxyhemoglobin From Conventional Pulse Oximeter From invasive CO- Oximeter Blood Sample [Blood] Conventional pulse oximetry can not distinguish between COHb, and O 2 Hb

25. Signs and Symptoms SpCO%Clinical Manifestations <5% None 5-10% Mild headache, tire easily 11-20% Moderate headache, exertional SOB 21-30% Throbbing headache, mild nausea, dizziness, fatigue, slightly impaired judgment 31-40% Severe headache, vomiting, vertigo, altered judgment 41-50% Confusion, syncope, tachycardia 51-60% Seizures, unconsciousness Carbon Monoxide Poisoning Presents Like the Flu!

26. Laboratory CO-oximetry

27. Pulse CO-oximetry

28. Hgb Signatures: Physics of O 2 Pathways

29. Red FDA Validation Rainbow SET Compared to Reference Methodology Noninvasive measurement provides clinically equivalent results for HbCO without invasive blood draw (+ 3% from 0 – 40%)

30. 14,438 Patient Brown University Study Partridge and Jay (Rhode Island Hospital, Brown University Medical School), assessed carbon monoxide (CO) levels of 10,856 ED patients 11 unsuspected cases of CO Toxicity (COT) were discovered. Overall mean SpCO was 3.60% Occult COT was 4 in 10,000 during cold, 1 in 10,000 during warm months They concluded “unsuspected COT may be identified using noninvasive COHb screening and the prevalence of COT may be higher than previously recognized” Non-Invasive Pulse CO-Oximetry Screening in the Emergency Department Identifies Occult Carbon Monoxide Toxicity. Suner S, Partridge R, Sucov A, Valente J, Chee K, Hughes A, Jay G. J Emerg Med 2008 Department of Emergency Medicine, Rhode Island Hospital, Brown Medical School, Providence, RI.

31. Methemoglobinemia Cyanotic Chemical Guardian Protocol – Health surveillance for cyanosis causing chemical handlers (pre-placement, routine, high risk assignment clearance and symptomatic workers).

32. Causes of Acquired Methemoglobinemia Soda and other foods with phenol based preservatives Nitrogen based fertilizers Nitrate laden preservatives (such as saltpeter used to cure BBQ meats) Infantile diarrhea (high intestinal pH promotes gram-negative organism growth, converts dietary nitrates to nitrites) Benzocaine & Cetacaine sprays Dapsone EMLA Creams Chloroquine Flutamide Lidocaine Nitrates Nitric oxide Nitroglycerin Nitroprusside Iatrogenic Causes:Others (community based): Ash-Bernal R, et al. Acquired Methemoglobinemia A Retrospective Series of 138 Cases at 2 Teaching Hospitals. Medicine Sept 2004;83(5):265-273. Industrial Causes: More than 112 chemicals used in manufacturing and finishing plants: aniline, dinitrobenzene…

33. Symptoms of Methemoglobinemia Source: David C Lee, MD, Research Director, Assistant Professor, Department of Emergency Medicine, North Shore University Hospital and New York University Medical School SpMet% Clinical Manifestation 0-3% Normal concentration, no symptoms 3-15% Slight skin discoloration (palor, gray, or blue) may be present 15-20% Patient may be relatively asymptomatic, cyanosis likely 25-50% Headache, dyspnea, lightheadedness, weakness, confusion, palpitations, chest pain 50-70% Altered mental status, delirium Methemoglobinemia Can Present Like the Flu!

34. Traditional Diagnosis of MetHb Traditional marker: “chocolate brown” color of arterial blood Laboratory CO-oximeter

35. Limitations of Pulse Oximetry Barker SJ, Tremper KK, Hyatt J. Effects of Methemoglobinemia on Pulse Oximetry and Mixed Venous Oximetry. Anesthesiology 1989;70:112-117 [Blood] From invasive CO-Oximeter Blood Sample From Pulse Oximeter The 85% SpO2 “Push”: The difference between actual SpO 2 (blue) and display SpO 2 (red) (2 wavelength oximetry) in presence of methemoglobin

36. Noninvasive Pulse CO-Oximetry Oxygenated Hb and reduced Hb absorb different amounts of Red (RD) and Infrared (IR) Light (Two-wavelength oximeters cannot measure dyshemoglobins)

37. FDA Validations Rainbow SET Compared to Reference Methodology Noninvasive measurement clinically equivalent results for MetHb without invasive blood draw Equivalent precision and accuracy (+ 1% from 0-25%)

38. Perfusion

39. Nellcor Capnoprobe™ l US approval Jan 2003. l Research study: Children's Medical Center – Dallas TX. l 11 kids infected Burkholderia cepacia, 2 died. l Traced to saline solution packaging of probes. l 5,600 units @ 30 centers recalled FAIL

40. Perfusion Index Infrared Saturation Red

41. Infrared Signal 0.254-0.253 = 0.001 0.253- 0 = 0.253 0.001/0.253 = 0.4% AC DC Perfusion index is the ratio of the variable absorption (AC) to the non-variable (DC) of the infrared signal. PI display ranges from 0.02% (very weak) to 20% (very strong)

42. Perfusion Index Perfusion Index is an objective method for measuring a patient’s peripheral perfusion Perfusion Index is an early indicator of deterioration

43. Datex-Ohmeda PIr ® Range 0.3%-10% Most Patients >0.7% Increases the validity of the SpO2 by locating the strongest pulse signal

44. Philips Range 0.3%-10% Optimal >1.0% < 0.3% is marginal reposition the site

45. Masimo Range 0.02%- 20.0%Select site with highest value Perfusion Index

46. 108 healthy adults and 37 critically ill patients (finger sensors) PI range: 0.3% to 10%, median 1.4% ROC used to determine the “cutoff” value 1.4% PI best discriminated normal from abnormal What is the “Normal” PI value? Lima, et al. CCM 2002

47. Photoplethysmography Absorption Time R IR Photodetector Pleth Waveform

49. Definition of PVI Pleth Variability Index (PVI) is a measure of dynamic changes in PI that occur during the respiratory cycle PVI is a percentage from 1 to 100%: 1 = no variability 100 = maximum variability PVI: fluid volume status High variability (high PVI) = volume depletion

50. Research on PI and PVI Ongoing…

51. Can we get oximetric hemoglobin? SpHb added in 2008

52. Jan 2012: Pronto-7 (for adults > 30 kg) Noninvasive, quick, and accurate spot-check hemoglobin testing Measures (Under 1 Minute) Total Hemoglobin (g/dL, g/L, mmol/L) – SpHb ( ± 1 g/dL at 1 SD) Oxygen Saturation - SpO 2 Pulse Rate - PR Perfusion Index - PI Touch Screen Navigation Multiple Printing Solutions Blue Tooth Wireless Multiple Patient Reports Stores Patient Test Information

53. Pronto 7 Accuracy Frasca D et al. Crit Care Med. 39(10); 2011; 2277-2282.

54. Ocular Scanner EyeMarker Systems™

55. Retinal imaging Pattern recognition: Botulism, neurotoxins Nerve Agents Carbon Monoxide Cyanide FAIL

56. Pulse CO-Oximetry Applications Screening during routine exams CO, Met, Hb baseline values Early detection and prevention Urgent screening Rapid assessment of exposed/injured workers Triage and assessment (including PI) Health and safety tool Monitoring high risk areas/workers

57. Questions? mikemcevoy.com