Improving Therapeutic Hypothermia in Cardiac Arrest Survivors: ICEPACS Training in Ontario

1. ICEPACS Training 2012

2. Base Hospitals

3. 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. Cooling after cardiac arrest saves lives… How is Ontario Doing? • 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 • Less than 1/3 of patients were successfully cooled to a target temperature of 32 to 34 °C within 6 hours of hospital arrival

5. Cooling after cardiac arrest saves lives… How is Ontario Doing? • SPARC Network: 36 hospital across Southern Ontario • These results suggest that additional strategies are needed to increase use of this life-saving and brain-protecting treatment • EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.

6. The ICEPACS Trial:Initiation of Cooling by Emergency medical services to Promote the Adoption of in-hospital 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 • EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.

7. Overview: History of Pre-Hospital Cooling • Several small trials have evaluated pre-hospital cooling • The largest trial to date of pre-hospital cooling in Australia (Bernard et al, 2010) was still very small, only enrolling 234 patients • Failed to show any benefit for patients that received pre-hospital cooling • Rates of in-hospital cooling in this controlled trial were 100% • But we know from SPARC, in the real world less than 1/3 of cardiac arrest patients are being successfully cooled - we want to do better!!!

8. 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 incidence of important clinical adverse events has been documented in any of the existing pre-hospital cooling studies (Kämäräinen et al, systematic review 2009)

9. Who Is Eligible For Cooling? • 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) • Age > 18 yrs • Patient is unresponsive to verbal stimulus in AVPU score • Randomized to receive “ICE PACS” therapeutic hypothermia

10. Who Is NOT Eligible For Cooling? • Traumatic cardiac arrest including burns (hanging and electrocution are not excluded unless severe trauma is involved) • Sepsis or serious infection suspected as cause of cardiac arrest • Active severe bleeding • Suspected hypothermic cardiac arrest • Known coagulopathy (medical history or medications; Coumadin, Dabigatran / Pradaxa, Warafarin ) ASA and plavix are permitted. • Any verbal or written DNR • Obviously pregnant • Known prisoner

11. Randomization Procedure • One sequential, numbered, opaque, sealed envelope (SNOSE) will be inserted in ALS medication bag. • Paramedics must request a replacement from a supervisor if the randomization envelope is used during a call

12. Inside envelope: Randomization Card • Randomization: COOL PATIENT OR • Randomization: DO NOT cool patient

13. Cool Patient Do NOT Cool Patient Post – Arrest: Open Randomization Envelope - What’s Next? Give Midazolam DO NOT Open Cooler Open Cooler Provide Standard Post-Arrest care Apply Frozen packs Start infusion of 2L of chilled saline Discard Mock Wrist Band Apply Wrist Band and Ankle Band Record Randomization # Record Randomization # PCR Narcotic Tracking Sheet *indicate NO cooling Initiated PCR Narcotic Tracking Sheet *indicate COOLING Initiated Give Patient Chart Insert to treating MD/RN Give Patient Chart Insert to treating MD/RN

14. Documentation For ALL patients, document the following on the ePCR: • Was patient randomized for cooling:  Y / N • ICE PACS Randomization #: • Did patient  actually get cooled:  Y / N • If yes, was the wrist/ankle band applied? Y/N • Were the frozen packs applied? Y/N • Cold saline infused? If yes, estimate amount (ml)

15. Documentation (cont’d) • 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

16. Equipment • Waterproof envelope slip (In ALS medication bag, containing envelope) • Envelope(containing randomization items) • Randomization Card • If randomized to cooling: Wrist band and Ankle band • If randomized to cooling: Patient Chart Insert • Cooler • IV Tubing in cooler • Frozen packs (to be used as ice-packs) • Cold Saline (for infusion) ICE-PACS

17. 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

18. Randomized to Cooling: Procedure • Give first dose of midazolam (5 mg IV) • Gel pack placement - order of preference: Carotids, Axilla, Femoral. Apply bilaterally where possible (3 bags in total) • Start infusion of cold saline using cold IV tubing using (total 2 liters) • Apply wrist band and ankle band to patient • Record randomization number • Give study notification patient chart insert to treating MD/RN

19. 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)

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

21. 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. (Ice packs can still be used for surface 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!

22. 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 (allows for BP range down to > 90 mmHg if the initial BP was ≥ 100 mmHg) • In both situations: • Can continue surface cooling • Leave wrist band and ankle band in place!

23. Equipment Storage Randomization Envelopes in ALS Drug Bag • Restock by contacting a supervisor • When re-stocking ensure the envelope is placed back into the ALS drug bag and the Narcotic tracking sheet is filled out Cooler: • Cooler will be fastened in EMS vehicles And remember…

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

25. Start of Shift • 3 Frozen Gel packs from freezer into cooler • 2 Chilled bags from fridge into cooler, placed between Gel packs • Place IV tubing into cooler (to keep it cold!) • Re-stock fridge and freezer • **Ensure frozen packs is replaced at the start of every shift** • End of shift • Document on Narcotic Tracking Log • Notify Supervisor if you require a randomization envelope • Peak trucks, replace frozen packs and cold saline into fridge / freezer

26. FAQs and Answers 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 vein)

27. FAQs and Answers 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. 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

28. FAQs and Answers 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.

29. FAQs and Answers Q: Why can’t BLS paramedics initiate cooling for ICE-PACS? A: BLS paramedics can still do a great deal to help during resuscitation of a cardiac arrest. (REMEMBER TO USE THE POST-ROSC CHECKLIST.) For the time being, we want cooling interventions to be delivered as a complete package as much as possible (i.e. cold saline infusion + frozen packs + midazolam). Q: What should I do if I have initiated cooling and have now identified that my patient is having a STEMI? A: Contact the interventionalist as per normal and indicate that your patient is being actively cooled with IV cold saline as per a hypothermia directives. Q: Can I use the CVAD route to infuse cold saline if I don’t have a peripheral IV? A: No… The CVAD sits very close to the heart and there is no evidence that indicates that it would be safe to administer cold saline via this route and may potentially increase the risk of arrhythmia.

30. 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: rescuresearch Website: http://www.rescu.ca

31. QUESTIONS?