1. ICE-PACS ICEPACS Training 2013

2. ICE-PACS Base Hospitals

3. ICE-PACS ICEPACS CME Training Contents  Cooling Post-Cardiac Arrest in Ontario  Overview: Pre-Hospital Cooling and the ICE-PACS trial  Practical Issues: Randomization, Eligibility, How to Cool, Equipment and Storage  Frequently Asked Questions

4. ICE-PACS SPARC Network: 36 hospital across Southern Ontario  A 2-year comprehensive educational program to increase application of in-hospital cooling to cardiac arrest survivors  Even after this large and expensive project, cooling was still only attempted in about half of eligible patients and often with great delays (less than 1/3 cooled within 6 hours). It's time to start thinking about cooling eligible patients as soon as possible, similar to how we currently triage STEMI patients to obtain prompt diagnosis and treatment." Cooling after cardiac arrest saves lives… How is Ontario Doing?

5. ICE-PACS The ICE-PACS Trial: Initiation of Cooling by Emergency medical services to Promote the Adoption of timely therapeutic hypothermia in Cardiac arrest Survivors  RCT comparing pre-hospital initiation of cooling by EMS providers versus usual post-resuscitation care  GOAL: to increase the number cardiac arrest survivors that are successfully cooled to target temperatures (32 to 34 degrees) within 6 hours of hospital arrival by starting the cooling process sooner  Overall goal is to improve clinical outcomes for cardiac arrest survivors

6. ICE-PACS How Can ICE-PACS Help Our Patients?  ICE-PACS seeks to change the way we think about treating cardiac arrest survivors  Shift focus from “where” treatments can be provided (i.e. In or out of hospital) to “when” treatments are provided.  Analogy: Paramedics already save thousands of lives each year by recognizing STEMI early to prevent delays in diagnosis and hasten access to treatment. ICE-PACS tests whether this kind of earlier recognition and treatment with cooling can also prevent delays and save lives

7. ICE-PACS Theoretical Risks – Common Questions  Cooling is generally safe and well tolerated  The more frequent side effects:  shivering  peripheral vasoconstriction  sinus bradycardia  cold diuresis  electrolyte disturbances  No increased incidences of serious clinical adverse events have been documented in any of the existing small pre-hospital cooling studies (Kämäräinen et al, systematic review 2009)

8. ICE-PACS  Defibrillation and/or chest compressions by EMS providers (including fire fighters) for pulseless cardiac arrest  ROSC sustained for > 5 minutes  SBP > 100mmHg (even if needing dopamine)  Patient is intubated  Patient GCS is <10  Age > 18 yrs  Randomized to receive “ICE PACS” therapeutic hypothermia Who Is Eligible For Cooling?

9. ICE-PACS  Traumatic cardiac arrest including burns  Sepsis or serious infection suspected as cause of cardiac arrest  Active severe bleeding  Suspected hypothermic cardiac arrest  Known coagulopathy (medical history or medications; ASA and plavix are permitted)  Any verbal or written DNR  Obviously pregnant  Known prisoner Who Is NOT Eligible For Cooling?

10. ICE-PACS  One sequential, numbered, opaque, sealed envelope (SNOSE) will be inserted in ALS medication bag  An additional envelope will be kept in drug cupboard on the truck Randomization Procedure

11. ICE-PACS Inside envelope: Randomization Card  Randomization: COOL PATIENT OR  Randomization: DO NOT cool patient

12. ICE-PACS Post – Arrest: Open Randomization Envelope - What’s Next? DO NOT Open Cooler Record Randomization # Provide Standard Post-Arrest care ePCR and Narcotic Tracking Sheet *indicate NO cooling Initiated and record randomization # Call Cardiac Arrest Notification Line if NOT using ePCR ePCR and Narcotic Tracking Sheet *indicate NO cooling Initiated and record randomization # Call Cardiac Arrest Notification Line if NOT using ePCR Open Cooler Apply Frozen Gel Packs Apply Wrist Band and Ankle Band Record Randomization # Give Patient Chart Insert to treating MD/RN Cool Patient Do NOT Cool Patient Discard Mock Wrist Band ePCR and Narcotic Tracking Sheet *indicate COOLING Initiated, record randomization # and complete required sections of ePCR Call Cardiac Arrest Notification Line if NOT using ePCR ePCR and Narcotic Tracking Sheet *indicate COOLING Initiated, record randomization # and complete required sections of ePCR Call Cardiac Arrest Notification Line if NOT using ePCR Start infusion of 2L of chilled saline Give Midazolam Give Patient Chart Insert to treating MD/RN

13. ICE-PACS Documentation For all patients, document the following:  Was patient randomized for cooling: Y / N  ICE PACS Randomization #:  Did patient actually get cooled: Y / N If yes: wrist bands applied? Frozen packs? Cold saline infused? If yes, estimate amount (ml) If Patient was randomized to be cooled but was not, please document reason on ePCR:  Severe bleeding developed  Re-arrested  Cold saline stopped and not restarted  Cold saline stopped and restarted  No time to cool  Equipment malfunction/issues  Specify: i.e. saline not cold  Other: Please specify **If no ePCR - Please state reason on Cardiac Arrest Notification Line**

14. ICE-PACS Randomized to No Cooling: Procedure  Apply usual post-resuscitation care  Discard decoy wrist band contained in envelope  Record randomization number  Give study notification patient chart insert to treating MD/RN

15. ICE-PACS Randomized to Cooling: Procedure  Give first dose of midazolam (5 mg IV)  Frozen gel pack placement - order of preference: Carotids, Axilla, Femoral. Apply bilaterally where possible  Start infusion of cold saline using cold IV tubing using (total 2 litres)  Apply wrist band and ankle band to patient  Record randomization number  Give study notification patient chart insert to treating MD/RN

16. ICE-PACS Equipment  Envelope (containing randomization items)  Randomization Card (indicating whether patient is to be cooled or not)  If randomized to cooling: Wrist band and Ankle band  If randomized to NO cooling: 2 mock wristbands (discard)  If randomized to cooling or NO cooling: Patient Chart Insert  Coleman -15L Excursion Cooler  IV Tubing in cooler  Frozen gel packs (to be used as ice-packs)  Cold Saline (for infusion)

17. ICE-PACS Midazolam  Midazolam is given to prevent shivering during induction of cooling  Midazolam should be given to all patients that are randomized to cooling  SBP must be ≥ 100 (can be stabilized with dopamine and/or fluids)  Can give 5 mg IV bolus, followed by another 2.5 to 5 mg IV bolus after 5 minutes (max. total dose 10mg)

18. ICE-PACS Clinical Considerations  1st IV – dedicated line for ALS medications  Ideally 2 nd IV (preferably saline lock) for cold saline, run through COLD tubing kept in cooler  Ideally target left arm for both IVs (if possible)  ONLY If a 2 nd IV cannot be established AND patient NOT requiring dopamine, can use 1 st IV to infuse cold saline and usual (room temperature) tubing

19. ICE-PACS Clinical Considerations  Dopamine requires a dedicated IV line  If only 1 IV can be established and patient needing dopamine, then dopamine takes precedence over cold saline until a second line can be established. (frozen gel packs can still be used for surface cooling if patient is randomized for cooling)  The application of therapeutic hypothermia should not detract from rapid transport, optimizing ventilation and oxygenation, or the management of a re-arrest REMEMBER TO USE THE POST-ROSC CHECKLIST!

20. ICE-PACS Clinical Considerations  In the event of a re-arrest:  Discontinue cold saline  If SBP < 90 mmHg  DESPITE dopamine and fluids, discontinue cold saline until SBP ≥ 90 mmHg  Can continue cold saline as long as SBP > 90 mmHg  In both situations:  Can continue surface cooling  Leave wrist band and ankle band in place!

21. ICE-PACS Randomization Envelopes in drug cupboard  Restock in same manner as narcotics  When re-stocking ensure there are a total of 2 envelopes in vehicle (1 in cupboard, 1 in ALS medication bag) Cooler:  Cooler will be fastened to EMS vehicles or kept in a separate compartment Equipment Storage And remember…

22. ICE-PACS ***Leave the cooler in the ambulance! If randomized to cooling, can send for cooler or start cooling patient in the ambulance*** …There’s no need to carry so much!!!

23. ICE-PACS Start of Shift  3 frozen gel packs from freezer into cooler  2 Chilled bags from fridge into cooler, placed between frozen gel packs  Place IV tubing into cooler (to keep it cold!)  Re-stock fridge and freezer **Ensure frozen saline is replaced at the start of every shift** End of shift  Document on Narcotic Tracking Log  Replace randomization envelope  Notify Drug Tech if more randomization envelopes required

24. ICE-PACS Q: Why will the IV tubing kept in the cooler? A: The IV tubing will be kept in the cooler to keep it cold. Considerable heat loss can occur when the IV tubing is at room temperature, due to the exposure created by the large surface area of the tubing. Q: Why are we using a wrist band AND an ankle band when patients are cooled? A: These are intended to help remind in-hospital clinicians to cool. The wrist band should be easily visible to all and the ankle band is for cardiologists performing PCI (who might not look beyond the femoral artery) Q: Can the cooling contribute to an arrhythmia or increase pulmonary edema in our patients? A: The most common arrhythmia is sinus bradycardia, which usually doesn’t require any treatment. More worrisome arrhythmias are not usually seen in the temperature range targeted by therapeutic hypothermia (32 to 34°C), unlike severe hypothermia due to exposure (i.e. <30°C). There does not appear to be any increase in pulmonary edema due to the cold saline. FAQs and Answers

25. ICE-PACS FAQs and Answers Q: How quickly does the temperature change when cooling is initiated? A: Based on the Bernard Trial, the average temperature drop was about 1.5°C during transport to hospital Q: What are the next steps for EMS after the patient is cooled? A: Complete the patient chart insert, ensure to record all data requested on the ePCR, and provide patient insert to attending hospital staff Q: What will happen to cooled patients that we leave at the hospital? A: In-hospital clinicians will usually use the exact same strategies to continue hypothermia for 12 to 24 hours. These typically include surface cooling (ice-packs), more cold saline, and deep sedation. Occasionally neuromuscular blockers will be needed to stop shivering. Some centers have specialized cooling devices that will be used to help speed up the cooling process. Q: If we know cooling works, is it ethical to not simply cool all patients? A: We know cooling works when applied in hospital. The existing evidence shows pre- hospital cooling is likely to be safe, but the trials were small. If pre-hospital cooling in ICE-PACS doesn't improve outcomes, or is associated with harm, then it will help prevent widespread implementation, and allow medics to focus on other pre-hospital interventions that are proven to be helpful.

26. ICE-PACS FAQs and Answers Q: Do we have to lug the cooler onto every CA call? We already carry so much! A: This is a good point, and we agree! Remember, you can simply leave the cooler in the ambulance! All that is needed initially is the ICE-PACS randomization envelope in your medic bag. If the patient meets the inclusion criteria and has no exclusions, open the envelope. If the patient is randomized to cooling, then instead of lugging the cooler to the scene, cooling can start in the ambulance en route to the hospital. Once in the ambulance, please remember to place the wristbands on the patient, add the cold gel-packs and run a line for the chilled-saline. All randomized patients – including those randomized to “no-cooling” – need to have their randomization number recorded on the ePCR and will have a patient chart insert in the envelope that should be provided to the ED staff. Q: Is the main goal of the study remind the ED staff to cool in-hospital, or to “do the work that doctors and nurses should be doing”? A: This is FALSE! The goal of this study is to see if starting cooling sooner will help more patients to reach the target temperature of 32-34 degrees within 6 hours, and whether this in turn can help more patients achieve improved outcomes. This study hopes to change the way we think about treating cardiac arrest survivors. Rather than focusing on “where” treatments can be provided (for example, in the field versus in the hospital), we believe paramedics can play a vital role in improving “when” treatments are provided. We know that paramedics already save many lives each year by recognizing STEMI early to prevent delays in diagnosis and hasten access to treatment. In the same way, this study tests whether earlier recognition and treatment with cooling after cardiac arrest by paramedics can also prevent delays and save lives.

27. ICE-PACS FAQs and Answers Q: Do Rescu researchers receive incentives or rewards for participating in ICE-PACS? A: None of the physicians or researchers involved in this trial receives any incentives for their work on this study. The main benefit for doctors running these trials (such as Dr. Laurie Morrison and Dr. Damon Scales) is their academic recognition in the medical society, and the satisfaction of working with paramedics to improve the healthcare system. Although incentives have previously been provided to paramedics for participating in trials, we now know that this is considered unethical because it creates the potential for a conflict of interest and could unintentionally lead to more ineligible patients being enrolled. This is especially important because cardiac arrest survivors are usually unconscious and incapable and so can’t make decisions about participating in research (the research is conducted using a waiver of informed consent). The ICE-PACS study is funded by the Canadian Institutes for Health Research and not by a pharmaceutical company, which means that there are no financial conflicts of interest but also that there is a very tightly-controlled and limited budget!

28. ICE-PACS Saving lives through Science, Innovation and Collaboration Rescu is the largest research program of its kind in Canada. Our research focus is to derive and evaluate processes of care and timely interventions that improve outcomes for patients who suffer life threatening trauma and cardiac emergencies in the out of hospital setting. The program has an established relationship with investigators and EMS from regions in Ontario serving a population of 8.8 million people in Ontario and includes 43 academic and community hospitals as our destination hospitals. Together the land EMS agencies respond to over 600,000 patient requests for care per annum. For more information, please see our quarterly newsletter sent to your EMS email and visit as at the following: Website: http://www.rescu.ca rescuresearch

29. ICE-PACS QUESTIONS?