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ROC ALPS

ROC ALPS. A miodarone, L idocaine, or P lacebo S tudy. Clark, Clackamas & Washington Counties. Inclusion Criteria. YES:. Non-traumatic out-of-hospital cardiac arrest Vascular access (IV or IO) Persistent/recurrent VF/VT after 1 (or more) shocks…. NO:.

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ROC ALPS

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  1. ROC ALPS Amiodarone, Lidocaine, or Placebo Study Clark, Clackamas & Washington Counties

  2. Inclusion Criteria YES: • Non-traumatic out-of-hospital cardiac arrest • Vascular access (IV or IO) • Persistent/recurrent VF/VT after 1 (or more) shocks… NO: • Open label IV amiodarone or lidocaine use in-field1 • Known hypersensitivity or allergy to amiodarone or lidocaine • Protected population (prisoners, minors, pregnancy, trauma deaths) • Those with a “No Study” bracelet 1excludes use of IO lidocaine to minimize pain when inserting/flushing IO line

  3. Inclusion continued… • What counts as a “shock”? • ROC-EMS agency administered shock(s) • First responder or BLS-AED delivered a shock • ALS delivered a shock • PAD/non-ROC agency shock(s) • Not ICD shock(s)

  4. Inclusion continued… • What is persistent/recurrent VF/VT? • Confirmed VF/pulseless VT (operationally, pulseless means needing CPR) seen anytime after first shock • If thinking antiarrhythmic drug for VF/pulseless VT… give ALPS drug • Estimated 17% of codes

  5. Drug Kit Design Three (3) identical (blinded) syringes

  6. ClearLink Adapter Kits will be packaged with a Baxter ClearLink Adapter Adapter must be used to ensure compatibility with all IV infusion sets

  7. Study Protocol • Cardiac Arrest—VF/pulseless VT • Defibrillate @ 200j & immediately continue CPR • Establish IV/IO access • Check rhythm after 2 minutes of CPR • Still in VF/pulseless VT? • Defibrillate @ 300j & immediately continue CPR • Give epinephrine1mg • Check rhythm after 2 minutes of CPR • Still in VF/pulseless VT? • Defibrillate @ 360j & immediately continue CPR • Give ALPS Syringes #1A and#1B

  8. Study Protocol continued… • Still in VF/pulseless VT? • Defibrillate @360j & immediately continue CPR • Give epinephrine 1mg • Check rhythm after 2 minutes of CPR • Still in VF/pulseless VT? • Defibrillate @ 360j (#5) & immediately continue CPR • Give ALPS Syringe #2

  9. Important Points • Study drugs need to be given as soon as possible! • Within 10 minutes or lessafter arrival (preferably sooner). • Study drugs can be given immediately following epinephrine (must flush tubing first). • Regulatory agencies will monitor this very carefully.

  10. What if VF/VT Returns? • Carry out the full ALPS Protocol What if I gave syringes #1A and #1B, got pulses (ROSC) back, but VF/pulseless VT later returns? • Shock again • If this shock fails to stop VF/VT, give syringe #2

  11. What about late-occurring VF/VT? • VF/pulseless VT is treated the same way anytime it recurs after 1 or more prior shocks. This applies to: • VF/VT on EMS arrival • VF/VT arrest after EMS arrival • Late-occurring VF/VT • Anytime VF/pulseless VT returns after 1 or more prior shocks→ give ALPS drug ASAP

  12. Is the first dose of the study drugtwo syringes or one? • Two syringes • First Dose = Syringe #1A and Syringe #1B • Second Dose = Syringe #2 • Exception = Small persons

  13. What if VF/VT persists (or recurs) after I give all the study drug? • May use other antiarrhythmics available to the agency (e.g., magnesium) • Additional shock(s) • NOopen label amiodarone or lidocaine in field permitted before or after ALPS drug* Further management at discretion of providers… *excludes use of IO lidocaine to minimize pain when inserting/flushing IO line.

  14. If any syringe in the kit is broken upon opening… Patient excluded from study (DC ALPS) Open label lidocaine or amiodarone, if needed Usual drug doses If at least 1 ALPS syringe has already been given… Patient excluded from study (DC ALPS) Open label lidocaine or amiodarone, if needed Limit lidocaine to ≤ 200 mg (total dose) May use amiodarone at usual doses What if one or more of syringes is broken, or gets broken before/while being given?

  15. Drug Kit Peel-off Barcode labels PCR Affix to… Hospital Notification Sheet

  16. “Opt-Out” Option • A “No Study” bracelet will be provided for people who do not want to participate. • Do not enroll a patient in the study if they are wearing this bracelet; use standard resuscitation protocol. • The patient or family may also later opt-out of continued data collection

  17. After Enrollment • If you enroll a patient, call 1-800-xxx-xxxx as soon as you are able. • ROC is required by law to notify all patients or their families they were enrolled. • Once notified, they or their family will have the option of no longer participating. • Ensure that the receiving hospital emergency department is notified that the patient has been enrolled in ALPS. • This is for guidance on additional amiodarone and lidocaine, and to provide contact information for further questions.

  18. Documentation • Document what you would normally do in cases of cardiac arrest. • If your monitor is used, it will be critical to upload the “CPR process file” (.pco)from the incident. • Some monitors may have event markers to document when the ALPS syringes were given. • Additional documentation: • Time-stamp each dose (syringe number) of ALPS drug. • Document the shock number that follows each dose of ALPS drug. • Study drug kit number (bar code).

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