1. The Prehospital & Transport Medicine Research Program Sunnybrook Health Sciences Centre

2. Objectives Resuscitation Outcomes Consortium (ROC): ROC P.R.I.M.E.D. –Impedance Threshold Device (ITD) –Early versus Later Analysis –Optimizing CPR ZOLL E Series –New defibrillation pads –The transfer of data

3. ROC Sites  Birmingham, AL  Dallas, TX  Iowa City, IA  Milwaukee, WI  Pittsburgh, PA  Portland, OR  Ottawa/OPALS/B.C.  San Diego, CA  Seattle/King Co., WA  Toronto, ON

4. Participating Toronto Sites (Toronto Regional RESCUeNET) Durham Hamilton Muskoka Ontario Air Ambulance Program Peel Simcoe Toronto York

5. Toronto Regional RESCUeNET 8 EMS Services 32 Fire Services 28 Dispatch Centres 5 Base Hospitals 53 Receiving Hospitals

6. EPISTRY Enrollment* SiteCATrauma Air Amb.173 Durham235106 Hamilton29233 Muskoka577 Peel260 Simcoe23726 Toronto1084443 Total1932682 *Dec 1, 2005 to Sept 14, 2006

7. Please bear in mind….. First qualifying vitals; even if the vitals improve during the course of treatment (BP or GCS) Initial fluid bolus = ROC HS study fluid Call the enrollment line immediately after transferring care to the trauma team.

8. ROC HS Enrollment* SitePatients Enrolled Air Ambulance16 Hamilton4 Toronto8 Total28 *July 6 to Sept 15, 2006

9. P.R.I.M.E.D. Prehospital Resuscitation using an IMpedance valve and Early vs. Delayed analysis trial

10. P.R.I.M.E.D ITD ANALYZE EARLY VS. LATE

11. Impedance Threshold Device

12. ITD - What is it? Hemodynamic adjunct (not ventilatory adjunct) Used with BVM ETT Genesis II (Manual setting only)

13. Compression Increased intrathoracic pressure Compression of heart and lungs Understanding the ITD Decompression (recoil) Decreased intrathoracic pressure Refilling of heart and lungs  Complete chest recoil is critical!

14. ITD - What are we asking you to do?

15. Using the ITD with a Mask or ETT Ventilate using timing lights (10/minute) Mask = ventilate at 2 : 30

16. ITD Timing Lights Flash 10 times per minute = 10 breaths/min. (q 6 seconds) May be used to guide compression rate. (10 compressions / breath) Use timing lights when ETT established

17. If Ventilation Timing Lights Fail The ITD functions independent of timeing lights Turn off the lights and ventilate patient at proper rate (10 breaths/min).

18. Important Reminders Mask – Continuous & tight seal Connect ITD as soon as possible – start with mask then transfer to ETT Don’t hyperventilate (timing lights 10/min) Continue to use ITD if gasping or agonal breathing (in absence of a pulse).

19. Remove ITD immediately if: Chest does not rise. Device fills with fluid. Device breaks or does not function properly. Patient gets a pulse (ROSC).

20. Important reminders… Re-apply ITD immediately if patient re-arrests Do not open a second study kit The ITD is for single-patient use only No medication through ITD (impede function) All trials are PREHOSPITAL and end on arrival to the ED.

21. Supplies 1 Study kit (Genesis pocket of airway bag) Restocking points: Sunnybrook St. Mike’s Call enrollment line 1-866-nrol-911

22. Analyze Early vs. Analyze Late

23. What is it?

24. Randomized to Either: …then analyze rhythm 30+ sec. of CPR Analyze EARLY …then analyze rhythm 3 minutes of CPR Analyze LATER

25. Why are we doing this?

27. What are we asking of you?

28. Analyze Early

29. Analyze Late DO NOT interrupt CPR to perform ALS procedures

30. Remember… Bystander CPR does not count, you must still do CPR per study protocol Analyze early or analyze late assignment will be determined by the first arriving vehicle

31. Randomization Device level: Each defibrillator is assigned (centrally by serial number) to either Early or Later Analysis Via: Dog Tags Switching: At ~ 9 months the devices will be re-randomized

32. Indications (both protocols) Patients ≥ 18 years of age Non-traumatic out of hospital cardiac arrest Non-traumatic out of hospital cardiac arrest Patients ≥ 18 years of age Non-traumatic out of hospital cardiac arrest Non-traumatic out of hospital cardiac arrest

33. Contraindications (both protocols) Pre-existing DNR order. × Pre-existing DNR order. × Known pregnancy. × Known prisoner × Known prisoner. Pre-existing DNR order. × Pre-existing DNR order. × Known pregnancy. × Known prisoner × Known prisoner.

34. Contraindications: Analyze Early or Analyze Later × EMS-witnessed arrest (shock immediately) × AED / defibrillator pads attached prior to your arrival by: × Non-ROC responders - EMS or fire services OR × PAD, law enforcement, layperson OR × Off duty medic or fire fighter, medical professional, etc. Consider enrolling ITD only

35. Contraindications: ITD × Tracheostomy × Mechanical CPR × Patient with a pulse

36. Study Kits Inside: Study name & randomization number Inclusion / exclusion criteria 1 King mask 1 ITD (mini extension tube attached) Paramedic Data Collection Sheet 1 Arm Band “Notification of Study Enrollment” Sheet “Research Data Collection Envelope” Extra labels with randomization number

37. After Transfer of Care

38. ITD Packaging & Randomization Labels Randomization Labels

39. Hospital Documentation After you have transferred care to the ED staff please ensure the following has been completed: The patient bracelet has been placed on the patient’s arm The “Notification of Study Enrollment” sheet has been given to the documenting nurse A study label has been affixed to the ED chart

40. Your Documentation Please ensure the following has been completed: “ROC PRIMED Paramedic Data Collection Sheet” Adverse events or concerns have been reported Study labels have been affixed to: the ACR (white & yellow copies); and “Research Data Collection Envelope” the patient’s chart All documents have been placed in the “Research Data Collection Envelope” Upload defibrillator data

41. ZOLL E Series New Defibrillator Pads Data Transfer

42. Optimize CPR Rate – 100/min Depth – 1 1/2 to 2 inches Release - complete recoil Five key aspects of CPR Uninterrupted Ventilation – 10/min Incomplete chest recoil will interfere with the ability of the ITD to improve blood flow to heart. ! !

43. ZOLL E-Series CPR-D padz Rate of compression Rate of ventilation Depth of compression Hands off time

44. ZOLL E-Series CPR-D padz / Defib Cable Adaptor Insertion point for CPR-D padz cable Insertion point for defibrillation cable

45. ZOLL E-Series CPR-D padz / Defib Cable Adaptor IMPORTANT to Know ! ! You can defibrillate without the adaptor

46. ZOLL E-Series Connection to Computer (Cable) Rear panel of defibrillator Serial cable from defib to computer

47. ZOLL E-Series Transferring Data 1. Turn selector switch off 2.Wait 10secs; press & hold left-most soft key and turn selector switch to on.

48. ZOLL E-Series Transferring Data 3. Activate “RescueNet Code Review” on MobiCAD by pressing ZOLL RescueNet Code review icon.

49. ZOLL E-Series Transferring Data 4. In RescueNet Code Review select Serial Cable icon

50. ZOLL E-Series Transferring Data 5.Press Upload Trend softkey 6.Select RS-232

51. ZOLL E-Series Transferring Data 7.Press Send softkey

52. ZOLL E-Series Transferring Data Unit displays progress bar

53. ZOLL E-Series Transferring Data Following successful transmission Card Uploaded

54. Adverse Event? Pulmonary edema. Suspected device malfunction, including timing lights. If you feel protocol may have led to a safety problem for the patient and/or EMS Any other study-related issue that may have effected the patient or you.

55. What do you do if you encounter an Adverse Event? Call the enrolment line

56. Questions / Comments / Concerns? Jamie Frank (416) 480-6100, ext. 3451 Jamie.Frank@sunnybrook.ca Call or e-mail