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ResQTrial (Lancet 2011) vs ROC PRIMED (NEJM 2011)

ResQTrial (Lancet 2011) vs ROC PRIMED (NEJM 2011). The Devil is in the Details R. J. Frascone, MD, FACEP Medical Director EMS Regions Hospital EMS, St. Paul, MN

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ResQTrial (Lancet 2011) vs ROC PRIMED (NEJM 2011)

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  1. ResQTrial (Lancet 2011)vsROC PRIMED (NEJM 2011) The Devil is in the Details R. J. Frascone, MD, FACEP Medical Director EMS Regions Hospital EMS, St. Paul, MN Professor of Emergency Med University of Minnesota 1

  2. These trials were studying two different things, in two very different ways The RESQ Trial studied the combination of ACD/ITD CPR vs S-CPR ROC PRIMED studied ITD CPR vs S-CPR

  3. But, • The RESQ Trial looked at only ACD/ITD vs S-CPR • ROC PRIMED looked at two different things: Early vs late defibrillation and ITD CPR vs S-CPR and they did it with a multifactoral approach • Both trials were complex, but PRIMED was extraordinarily complex

  4. First A Review(sorry)

  5. Standard CPR

  6. Cardiac Pump Theory: Heart squeezed between sternum and spine. Thoracic Pump Theory: Chest acts as bellows. Compression causes positive intrathoracic pressure: Blood leaves the heart from higher pressure state (inside the heart) to the lower pressure state (systemic circulation) Background: Circulation during CPR Compression Phase 7

  7. Background:Circulation during CPR Vacuum develops in the chest, drawing air back into the lungs and blood back into the heart (preload). ↑ PRELOAD leads to ↑ CARDIAC OUTPUT Chest Wall Recoil Phase 8

  8. Inefficiencies of ConventionalStandard CPR (S-CPR) 10

  9. Inefficiency #1 • Filling of the heart (preload) is dependent upon the chest wall’s ability to recoil during decompression phase. • Chest wall recoil may be compromised by: • A stiff chest • Broken ribs • Just doing it wrong 11

  10. Inefficiency #2 Air rushes in through an open airway and wipes out the vacuum we’re relying on to fill the heart. Heart stops filling as soon as vacuum is equalized. 13

  11. ACD CPR

  12. ACD CPR device Metronome Force Gauge Suction Cup Handle 15

  13. ACD CPR: Compression • Actively compressing the chest, increasing IP pressure and thereby forcing blood out of chest, just like s-CPR. • Same position as standard CPR • 40 – 50 cm (1 ½ - 2”) • Soft chest: 65 lbs • Average chest: 90 lbs • Stiff chest: 110 lbs 16

  14. ACD CPR: Decompression But, unlike S-CPR it actively decompresses the chest,decreasing IP pressure, thereby drawing blood into the chest. • Typically 15-20 lbs 17

  15. ACD-CPR Optimizes Chest Wall Recoil S-CPR ACD-CPR 18

  16. Does it Work?

  17. ACD CPRThe Problem is: Air rushes in through an open airway and wipes out the vacuum we’re relying on to fill the heart. Heart stops filling as soon as vacuum is equalized.

  18. The Solution • Enter the Impedence Threshold Device (ITD)

  19. Airflow Through the ITD Chest Compression Patient Ventilation Patient can freely exhale. Patient can be freely ventilated. 25

  20. Airflow Through the ITD Spontaneous Breathing Air will enter if patient creates at least -10 cmH2O pressure with respiratory effort. Chest Decompression Influx of air is prevented, enhancing the vacuum in the chest. 26

  21. Effect of Inspiratory Impedance Greater vacuum (negative pressure) in the chest during chest wall recoil phase 27

  22. Airway Pressures in Patient in Cardiac Arrest: ITD + ACD CPR (scale in mmHg) ACD CPR w/ Sham ITD ACD CPR w/ Facemask + ITD ACD CPR w/ ET + ITD Ventilation 28 Plaisance et al. Crit Care Med 2005;33(5):990-994

  23. Improved Blood Pressure mmHg P<0.05 for differences between S-CPR & S-CPR + ITD, and ACD-CPR & ACD-CPR + ITD 29 Pirrallo et al. Resuscitation 2005;(66):13-20 and Plaisance et al. Circulation 2000;(101):989-994.

  24. Many other trials both in animals and human that prove the effectiveness of the ITD alone or in combination with ACD

  25. Putting it all together ACD/ITD CPRin humans

  26. Paris Survival Study:ACD CPR  ITD • Prehospital study • 200 patients/arm (ACD vs. ACD/ITV) • ROSC: • 38.5% - ACD • 48% - ACD/ITV • ICU admission • 28.5% - ACD • 39.5 – ACD/ITV • 24 Hour Survival • 22% - ACD • 32% - ACD/ITV

  27. The ResQ Trial

  28. Comparative Effects of Standard CPRVersus Active Compression Decompression CPR with Augmentation of Negative Intrathoracic Pressure for Treatment of Out-of-Hospital Cardiac Arrest: Results from a Randomized Prospective Study Tom P. Aufderheide, MD; Ralph J. Frascone, MD; Marvin A. Wayne, MD; Brian D. Mahoney, MD; Robert A. Swor, DO; Robert M. Domeier, MD; Michael L. Olinger, MD; Richard G. Holcomb, PhD; David E. Tupper, PhD; Demetris Yannopoulos, MD; Keith G. Lurie, MD 37

  29. Methods S-CPR (Control) ITD + ACD-CPR (Intervention) 39

  30. Hypothesis Survival to hospital discharge with favorable neurologic function (measured with a modified Rankin Scale [mRS] ≤ 3), is higher in patients receiving an ITD + ACD-CPR compared to patients receiving Standard CPR (S-CPR). 40

  31. Methods:Study Design • Prospective, randomized, controlled clinical trial with data analyzed on intent to treat basis • Seven US sites (population base: 2.3 million): • 46 EMS agencies • 4950 EMS providers • 25 IRBs • Patients assigned, based upon weekly block randomization, to control or intervention group • Study period: February 2005 – July 2010 • All study personnel blinded to aggregate data 41

  32. Results

  33. Results:Primary Endpoint * Survival to Hospital Discharge with Favorable Neurologic Outcome *53% improvement P = 0.019 OR 1.58 CI (1.07, 2.36) 43

  34. Results:Consistency Across Age Groups Survival to Hospital Discharge with Favorable Neurologic Outcome Age at Time of Arrest (years) 44

  35. Results:Consistency Across Genders Survival to Hospital Discharge with Favorable Neurologic Outcome P=1.00 for differences based on gender Odds ratio for effect of intervention based on gender: 1.60 95% CI (1.10, 2.33) 45

  36. Results:Consistent Benefit Throughout Enrollment Survival to Hospital Discharge with Favorable Neurologic Outcome

  37. Results:One-year Survival 47

  38. Conclusions Compared to standard CPR, ITD + ACD-CPR resulted in significantly increased survival to hospital discharge with favorable neurological function (53%). One year after OOHCA, survival rates with similar neurologic function were also significantly higher in the intervention group (49%). 48

  39. Resuscitations Outcomes Consortium (ROC) PRIMED Study Aufderheide et al. A trial of an impedance threshold device in out-of-hospital cardiac arrest. NEJM 2011365;798-806. 49

  40. Purpose To determine if use of an active (versus sham) ITD during standard CPR (no ACD used) would improve rates of hospital discharge with functional neurological survival in adult (modified Rankin Scale[mRS] score ≤3), non-traumatic, out of hospital cardiac arrests

  41. Description/Methods • 10 sites in US and Canada • Prospective, randomized, blinded • Subjects: adults with arrest from presumed cardiac etiology • 2 x 2 multivariate study design • Analyze Early (30 secs CPR) vs Analyze Later (3 min CPR) • Stiell et al. NEJM 2011 • Sham vs Active ITD • Aufderheide et al. NEJM 2011 • Impact of immediate CPR feedback utilizing QCPR device @ three sites • Hostler et al. BJM 2011

  42. Results

  43. Results Overall results in sham vs active ITD were similar (≈6%) November 2, 2009, NIH announced study terminated early (at the 2/3 enrollment point) as it was not going to be possible to detect any overall significant difference between either of the study groups (AnE vs AnL, or sham vs active ITD) even if study continued to 14,000 patients (stopped because of futility) No safety concerns with ITD

  44. Conclusion Compared with standard CPR, use of the ITD did not significantly improve functional survival from out-of-hospital cardiac arrest. When implemented under similar conditions, routine use of the ITD is not supported.

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