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Update on Cardiopulmonary Resuscitation

Update on Cardiopulmonary Resuscitation. Randall Brockman M.D. Cardiologist/Electrophysiologist Medical Officer for FDA. Circ System Devices Advisory Panel Sept 2004. Several Goals. To address important issues in clinical trial design for new CPR devices

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Update on Cardiopulmonary Resuscitation

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  1. Update on Cardiopulmonary Resuscitation Randall Brockman M.D. Cardiologist/Electrophysiologist Medical Officer for FDA Circ System Devices Advisory Panel Sept 2004

  2. Several Goals • To address important issues in clinical trial design for new CPR devices • To provide a clinical summary of the history of CPR and devices to assist with #1

  3. Chain of Survival • Rapid Access • Cardiopulmonary resuscitation • Early Defibrillation • Advanced cardiopulmonary life support

  4. The Beginnings of CPR • Resuscitation of arrest patients has been attempted for over a century • In the 1950’s, Safar et al and Elam et al “rediscovered” mouth to mouth • In 1960, Kouwenhoven described chest compression • These two techniques form the critical steps of modern CPR

  5. In-hospital Cardiac Arrest • Essentially unchanged over the last three to four decades • Return of spontaneous circulation (ROSC) in about 30% of patients • Approximately 15% of patients are discharged neurologically intact

  6. Interposed Abdominal Counterpulsation14 P=0.007 % occurrence P=0.02 P=NS

  7. Out-of-hospital Arrest • Hospital admission rates of 8-22% • Survival to discharge with intact neurologic function 1-8% • Largely unchanged despite multiple additions to the basic components of CPR

  8. No Long Term Benefit • High dose epinephrine • Short term improvement (ROSC, hospital admission) 17 • No long term improvement (hospital discharge and neurologic function) 17,18,19 • Vest CPR20 • Trend towards increased rate of ROSC and 24 hour survival but no difference in rate of hospital discharge • Transcutaneous pacing21 • No improvement in rates of hospital admission or discharge

  9. Active-Compression Decompression • Several studies found no improvement22,23 • Another study24 comparing ACD-CPR to S-CPR found improvement in several endpoints P=0.0004 P=0.002 % occurrence P=0.03

  10. Combination devices • Inspiratory impedance threshold devices combined with ACD-CPR26,27 P=0.033 P=0.02 P=0.41 % occurrence P=0.63

  11. Automatic External Defibrillators28,29 % occurrence

  12. Public Access Defibrillation30 P=0.03

  13. Summary • Survival rates with intact neurologic function have changed little over the past 30-40 years • Choosing appropriate endpoints for clinical trials will be important to determine which devices will facilitate improvement in long-term outcomes • Fostering an environment to enhance clinical research in this field will be important

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