Consider open-label amiodarone or lidocaine • Exactly! Open-label anti-arrhythmic can be given at that point. MEDSTAR - PHILIPS v. 1.0 41  HypoResus Enrollment Criteria - Out-of-hospital cardiac arrest - Persistent or recurrent VF/pVT after ≥1 shock - Age ≥18 years - Estimated downtime ≤30 minutes - No obvious signs of death (e.g. rigor mortis) - No known DNAR order - No obvious cause of arrest (e.g. trauma) MEDSTAR - PHILIPS v. 1.

1. Research Update
ALPS and new exclusion for
HypoResus

2. Objectives
• Review current & forthcoming ALS
management of adult cardiac arrest patients
in VF/pVT
• Demonstrate proficiency integrating ALPS into
the ALS portion of adult VF/pVT management
• Recognize new enrollment criteria for
HypoResus
• Identify incentives for proper enrollment of
research patients.
MEDSTAR - PHILIPS v. 1.0 2

3. Amiodarone Lidocaine Plain Saline
A L P S
MEDSTAR - PHILIPS v. 1.0 3

4. MEDSTAR: Your Hard Work &
Dedication Generate Great Results
• Phenomenal rates of ROSC: 30-35%
• Extremely impressive rates of Hospital
Discharge with good neurologic function: 8%
• We cannot save EVERY CPR patient, but your
exceptional CPR allows many citizens to return
home to their family and loved ones.
MEDSTAR - PHILIPS v. 1.0 4

5. Why Are We Here?
• Goal: Improve survival with good neurologic
function in OOH-CA
– This is the only truly meaningful endpoint
• Build on recent advances in CPR – “what works”:
– Effective CPR Process: rate, depth, fraction, etc.
– Prompt defibrillation with minimal pre- & post-shock
pauses
– Coordinated teamwork
• Take it to the next level…
MEDSTAR - PHILIPS v. 1.0 5

6. In A Nutshell: 1 Question
• Do anti-arrhythmics improve outcome
for OOH-CA VF/pVT?
– Improved ROSC?
– Improved Survival to Hospital Discharge?
MEDSTAR - PHILIPS v. 1.0 6

7. Rationale for ALPS Protocol
• ~24% of cardiac arrests are due to VF/pVT
• ~70% will refibrillate after 1st shock
• Mixed scientific evidence on anti-arrhythmics
– Beneficial? Harmful?
• Current options: Amiodarone & Lidocaine
• Prior studies: ↑ ROSC, but no survival benefit
• AHA Guidelines 2010: Class IIb (“may consider”)
• Randomized, controlled trial ONLY way to know
MEDSTAR - PHILIPS v. 1.0 7

8. New Amiodarone Formulation
• Current Amiodarone: Cordarone® & generic versions
– Diluted in polysorbate 80 (“Tween”)
– Causes hypotension – must be given slowly
– Foaming issues
– Adherent to plastic
• Requires all-glass packaging
• New Amiodarone formulation: Nexterone®
– Diluted in Captisol
– Does not cause hypotension – safe for bolus
– No foaming issues
– Plastic-friendly
• Allows for pre-filled, non-glass syringes in the future
• Currently FDA-Approved only in glass syringes
MEDSTAR - PHILIPS v. 1.0 8

9. How Does ALPS* Work?
*Amio – Lido – Plain NS – Study
• ALS Component:
– Each ambulance will have a single, barcoded ALPS
drug kit to be used for a single eligible patient in
persistent or recurrent VF/pVT
– The kits are blinded to all of us as to their contents
– The ALPS drugs will be given INSTEAD of open-
label anti-arrhythmic at the appropriate point in
the resuscitation
– Open-label epinephrine will be given ASAP, per
standard ACLS protocol
MEDSTAR - PHILIPS v. 1.0 9

10. No Conflict With “Official” AHA Or
Other Standards of Care
• Builds upon & reinforces the importance of high-
quality CPR recommended by AHA 2010
– Proper chest compressions delivery
– Proper ventilation techniques & rates
– Timely defibrillation for VF/pVT
– Administration of the same drugs
• The only operational difference is the emphasis
on early drug administration
– Epi & 1st dose anti-arrhythmic given back-to-back
ASAP after at least 1 shock (while charging for 2nd
shock).
MEDSTAR - PHILIPS v. 1.0 10

11. Inclusion Criteria
• Out-of-Hospital Cardiac Arrest
– Adults (> 18 yr of age)
– “Medical” CPR
– Persistent/recurrent VF/pVT after 1 or more shocks*
MEDSTAR - PHILIPS v. 1.0 11

12. What Is Persistent/Recurrent VF/pVT?
• Confirmed VF/pVT anytime at least 1 shock
– VF/pVT seen on 2nd or later rhythm analysis after
≥1 shock
• What counts as a shock?
– First Responder BLS Shock(s) with AED
– Bystander Shock(s) with AED
– MedStar ALS Shock(s)
– NOT AICD shock(s)!!!
MEDSTAR - PHILIPS v. 1.0 12

13. Exclusion Criteria
• Obvious trauma etiology (including burns)
• Exsanguination
• Known hypersensitivity/allergy to amiodarone or lidocaine
• Received open-label amiodarone or lidocaine in the field
– Even if it was only IO lidocaine for pain relief
• “3 Ps” of Protected Patient Populations
– Pediatric (< 18th birthday)
– Pregnant
– Prisoners
• Valid, written OOH-DNAR
• (“Unstable” VT w/pulse: this is a cardiac arrest protocol!)
MEDSTAR - PHILIPS v. 1.0 13

14. Foundation of Success:
Excellent “CPR Process”
• Compression rate: 100/min (120 max)
• Compression depth: ≥ 2” (5 cm) (adults)
• Complete recoil between down-strokes
• Emphasis on minimal (< 10 seconds!) interruptions &
ONLY for the following 2 interventions :
– Rhythm analysis (AED or manual defibrillator)*
– Shock delivery
• Not pausing during the first 6 minutes for other
reasons, including advanced airway
MEDSTAR - PHILIPS v. 1.0 14

15. The Perfect CPR Pit Stop
• Work together as a team
• Each member w/pre-assigned role
• Maximize efficiency
• Rotate compressors Q 1 minute (@rhythm √)
– Plan ahead!
• Having a timekeeper/scribe really helps
• No advanced airway for 6 minutes
• “Stay and play” for 10 minutes
MEDSTAR - PHILIPS v. 1.0 15

16. Efficient “Pit Crew” CPR Teamwork
1: Compressions (swap every 1 min w/#4)
2: Defib/AED & Mask Seal (help keep times)
3: CPR Card & Timekeeper
4: Squeeze bag (swap every 1 min w/#1)
5: IV/IO access ASAP & prepare drugs
(6: Document in laptop ePCR)
MEDSTAR - PHILIPS v. 1.0 16

17. 2-Handed Mask Seal
1-Handed Bag Squeeze
MEDSTAR - PHILIPS v. 1.0 17

18. MEDSTAR Scene Arrival
• Assess “C-A-B” & confirm cardiac arrest
• Start compressions (document start time!!!)
• Power on monitor*, apply puck, apply pads
• Start ventilations with BVM (NO AA yet!)
• Coordinate 1-minute CPR cycles with rhythm
check, shock (if needed)
• Start IV/IO & prep EPI + ALPS
MEDSTAR - PHILIPS v. 1.0 18

19. CPR with the MRx
1. POWER
--DEFIB MODE @ 150
2. PUCK
-- IS IT CONNECTED?
3. PADS
--PROPER PLACEMENT
4. NO LUCAS for 1st 6 minutes
--Manual Compressions ONLY
MEDSTAR - PHILIPS v. 1.0 19

20. Time-Keeping – Philips MRx
• Elapsed time
– Helps timing 1-minute CPR cycles, on-scene time
• Clock time
– Helps documenting ALS interventions
• Blue, 2-minute “progress bar”
– Helps timing 1-minute CPR cycles
– Drawback: ONLY resets after shock!
• Other dashboard information
MEDSTAR - PHILIPS v. 1.0 20

21. ALPS VF/pVT Protocol –
10:1 CPR No Pause for Breaths
#1 (150 J) #2 (150 J) #3 (150 J)
2 min of 2 min of 2 min of 2 min of ACLS
CPR* CPR* CPR* CPR*
{Obtain IV/IO access ASAP}
1st Epi
2nd Epi Consider
Flush
Flush Advanced
ALPS 1A &
ALPS2 Airway
ALPS 1B (if ≥ 100 lbs.)
Flush (King, ETT)
Flush
Rhythm Check & Shock, if needed
MEDSTAR - PHILIPS v. 1.0 21

22. ALPS Kit
MEDSTAR - PHILIPS v. 1.0 22

23. MEDSTAR - PHILIPS v. 1.0 23

24. Write run number
somewhere on the
kit.
ALPS Drug Kit
Peel-Off Bar-Coded Labels
and attach to orange sheet
Length: 7.75 in. Width: 4.5 in. Height: 1.75 in.
MEDSTAR - PHILIPS v. 1.0 24

25. ALPS Drug Kit
• 3 Identical, glass syringes (1A, 1B and 2)
• 3 mL of the same liquid in each syringe
• ALL contain either:
• 150 mg Amiodarone, or
• 60 mg Lidocaine, or
• Plain NS
MEDSTAR - PHILIPS v. 1.0 25

26. ClearLink Adapters Mandatory!
• Sterile, disposable
• Packaged in ALPS kit
• Can be used with all
ACLS medication
• MUST be used to
ensure COMPATIBILITY
with all IV infusion sets
• Attach to mediport and
leave it in place.
MEDSTAR - PHILIPS v. 1.0 26

27. ALPS Drug Kit
• First dose:
– 1A: First dose for all eligible patients
– 1B: Given together with 1A for patients ≥ 100 lbs.
(45 kg)
– Follow with a flush
• Second dose:
– 2: Second dose for all eligible patients
– Follow with a flush
MEDSTAR - PHILIPS v. 1.0 27

28. Documentation – Philips Markers
IV / IO
EPI
1 ALPS
2 ALPS
AMIODARONE
LIDOCAINE
KING TUBE
ETT
• Note: Push “1 ALPS” twice – once for syringe 1A and again for
syringe 1B (for patients ≥ 100 lbs./45 kg)
– Patients < 100kg will be given only syringe 1A for 1st ALPS drug dose
MEDSTAR - PHILIPS v. 1.0 28

29. When May I…..
• …Attempt Advanced Airway (King, ETT)?
– After at least 6 minutes (3 cycles) of CPR
• …Move patient?
– After at least 10 minutes of on-scene treatment
• Unless scene is unsafe
• …Field Terminate?
– 30 minutes of ACLS
MEDSTAR - PHILIPS v. 1.0 30

30. Advanced Airway Placement
• No advanced airway for at least 6 minutes*
– BVM with OPA or NPA only
• No strong scientific evidence supports early
advanced airway placement in OOH-CA
• Some evidence suggests it can be harmful
• CPR & defibrillation are “where it’s at” early
• Many patients won’t need it
• *Exception: active regurgitation
MEDSTAR - PHILIPS v. 1.0 31

31. Paperwork for Hospital
MEDSTAR - PHILIPS v. 1.0 32

32. What Happens In The E.D.?
• Medics give orange card to E.D. doc
– Remember to attach an ALPS kit barcode label!
– Written script indicates what drugs/doses may
have been given in the field
– Instructions to E.D.:
• Limit lidocaine to ≤ 100-120 mg over 2 hr in
E.D.
• No restriction on additional amiodarone
• All other E.D. treatments may be given p.r.n.
MEDSTAR - PHILIPS v. 1.0 33

33. Fire/EMS-Witnessed Arrest?
• Fire/EMS-witnessed < 5% of our CPRs
• “Immediate” rhythm check usually ~1+ minute
• So, treat them the same as EMS-Unwitnessed
– Immediate CPR while applying pads
– Rhythm check
– Pump while charging
– ALPS if eligible
MEDSTAR - PHILIPS v. 1.0 34

34. Broken ALPS Syringe(s)?
• Before ALPS drugs given, upon opening kit?
– Patient is excluded from ALPS – do not start
– Continue treatment with standard protocol
• After at least 1 ALPS syringe already given?
– Stop ALPS Protocol
– Use open-label Amio/Lido, if needed
• Lidocaine: limit to <200 mg total, cumulative dose
MEDSTAR - PHILIPS v. 1.0 35

35. Some Other “What Ifs”….
• Patient regurgitates prior to 6 min? Manage
the airway as needed, minimize interruptions
to compressions, document
– Avoiding over-ventilation may reduce the need
• Trouble with AA? Continue CPR with BVM
• Unsafe scene? Abandon protocol & report
MEDSTAR - PHILIPS v. 1.0 36

36. What If a Non-ROC Fire/EMS Agency
Arrives First & Performs CPR?
• Perform CPR per your EPAB protocol
• If patient meets ALPS criteria, they’re eligible
• NOTE: prior shock(s) count towards definition!
• If patient does NOT meet ALPS criteria, use
open-label epinephrine + amiodarone/lidocaine
– Example: Other agency gave open label meds
MEDSTAR - PHILIPS v. 1.0 37

37. What If a Bystander Arrives First?
Bystander: Anyone other than Fire/EMS
• They may perform CPR under your direction
• If patient meets ALPS criteria, they’re eligible
• NOTE: prior shock(s) count towards definition!
• If patient does NOT meet ALPS criteria, use
open-label epinephrine + amiodarone/lidocaine
– Example: Healthcare providers gave open label
meds
MEDSTAR - PHILIPS v. 1.0 38

38. What If All This Actually Works?
• Congratulations on ROSC!
• Hang on to ALPS kit, in case they die again
• EPAB ROSC protocol:
– 250 mL fluid boluses (hypothermia is OK!)
– Vasoactive drip (dopamine, etc)
– Avoid over-ventilation! High ETCO2 is expected!
– Patient Awakens with Advanced Airway:
• Give Versed for continued sedation
• Give Morphine/Fentanyl for stress response
MEDSTAR - PHILIPS v. 1.0 39

39. VF/pVT Returns After 1st ALPS Dose
• Scenario:
– ROSC after 1st dose of EPI+ALPS 1A/1B
– VF returns later?
– Charge, Shock & Give EPI+ALPS 2
– CPR X 2 minutes
• IOW, Anytime VF/pVT returns after ≥ 1
shock, give ALPS ASAP!
MEDSTAR - PHILIPS v. 1.0 40

40. VF/pVT Returns After All ALPS Drugs
Have Been Given
• Further management @ provider discretion…
• CPR, defibrillation, Epi every 3-5 min, etc….
• NO OPEN-LABEL Amiodarone or Lidocaine
may be given in the field before or after ALPS
drug (and no IO Lidocaine, either)
MEDSTAR - PHILIPS v. 1.0 41

41. “Unstable” Tachycardia with BP/Pulse
Occurs AFTER ALPS Drugs?
• Criteria:
– Hypotension, Altered LOC, Shock, Chest Pain, CHF
• Per EPAB/ACLS treatment guidelines**
– Cardioversion? YES
BUT
– **Amio or Lido? NO!!!!
MEDSTAR - PHILIPS v. 1.0 42

42. Do I Need An Amiodarone Drip?
• NO!!
• No known value of prophylactic antiarrhythmic
drug infusions after cardiac arrest
• Since no open label amiodarone or lidocaine can
be given in the field, no infusions of either of
these drugs should be given by EMS providers
– No IO lidocaine can be given for pain relief, either
• Duration of drug effect (“half-life”) should last
until E.D. arrival
MEDSTAR - PHILIPS v. 1.0 43

43. How does EPAB know I did this?
• Just like with HypoResus alert the Com Center
anytime a ALPS kit is used with run #.
• Do not throw away the kit!
• Write the run # on the kit and turn it back in
to the Logistics Team when they come to
restock the rig or at the end of your shift.
• Please document properly when ALPS is used
(a narrative note is good along with proper
drug therapy).
MEDSTAR - PHILIPS v. 1.0 44

44. DO
• Alert Com Center of ALPS enrollment and Run #
• Manual Compressions with puck for 1st 6 minutes
• Use only BVM + OPA for 1st 6 minutes
• Pump while charging
• Get an IV/IO ASAP
• Consider ALPS ANY TIME VF/pVT recurs/persists!
• Screen for patient weight: 100lbs or more?
• Give 1st dose ALPS (1A+1B) with 1st dose Epi
• Give 2nd dose ALPS with 2nd dose Epi
• Give drugs @ start of CPR cycle, if possible
• Stop ALPS any time a syringe breaks
• Document & download
MEDSTAR - PHILIPS v. 1.0 45

45. DON’T
• Interrupt compressions for > 10 seconds
• Attempt advanced airway for at least 6 minutes*
• Apply LUCAS device for first 6 minutes*
• Throw ALPS kit away
• Give ALPS drugs for:
– Trauma
– 3 Ps
– Prior Amio or Lido
• Give more Amio/Lido after all 3 ALPS syringes
• Move patient for at least 10 minutes (unless ROSC)
• Over-ventilate, even if elevated ETCO2 in ROSC
MEDSTAR - PHILIPS v. 1.0 46

46. ALPS Drug Dosing By Patient Weight
Patient < 100 lbs. (45 kg) Patient at least 100 lbs. (45 kg)
• 1st dose = ALPS 1A only! • 1st dose = ALPS 1A and 1B
Either way, give 1st dose
after 1st epi/flush
ASAP after 2nd shock
• 2nd dose = ALPS 2 • 2nd dose = ALPS 2
Either way, give 2nd dose
after 2nd epi/flush
ASAP after 3rd shock
MEDSTAR - PHILIPS v. 1.0 47

47. New Exclusion For HypoResus
MedStar has done an exemplary job
showing that it is feasible for us to
execute the HypoResus protocol. The
ROC now proposes a new challenge for
us. They are requesting that we focus
on patients that are more severely
injured. A high percentage of patients
that were not severely injured but
enrolled in HypoResus suffered from a
Ground Level Fall as their MOI.
Therefore we are now instructed to
continue the study while excluding all
patients that suffer from this MOI.
MEDSTAR - PHILIPS v. 1.0 48

48. Ground Level Fall Exclusion!
Excluded Patient Included Patient
• Fall from standing • Fall from >10ft
• Fall from seated • Fall from moving vehicle
• Fall from wheelchair • Fall from horse
• Syncope • Fall from tree
• Fall out of bed • Fall from ladder
• Fall from standing on any
object higher than the
ground.
MEDSTAR - PHILIPS v. 1.0 49

49. All other prior Inclusion and Exclusion Criteria should
still be followed!
Inclusion Criteria Exclusion Criteria
• Blunt or penetrating injury • Severe head injury with GCS <8
• Prehospital SBP <90 mmHg • >250 ml intravenous fluid given*
• Age >15 y/o • Any CPR
 Or >50 kg, if age unknown • Known prisoners
• Absence of severe head injury • Known/suspected pregnancy
 Or GCS >8 • Drowning or hanging
• Burns >20% TBSA
• Bilateral Paralysis
*Patient can receive up to 250 ml of fluid and still be eligible for enrollment.

50. Why bother with extra work?
Incentive Future of EMS
• We will be keeping track of all • The research we are doing
successful enrollments that here at MedStar is rewriting
the paramedic textbooks of
meet all inclusion/ exclusion. the future!
• There will be a raffle drawing • The research we do is insuring
for an American Express gift the quality of present
card. treatment and improving the
care we will provide in the
• Top enrolling Primary and future.
Secondary will receive an all- • Be a part of something special.
expenses paid trip to San There are few agencies that
Diego to attend the ROC get these kind of
opportunities.
Steering Committee Meeting.
MEDSTAR - PHILIPS v. 1.0 51