Comparative Study on Airway Management Methods in Cardiac Arrest Patients

1. Νέες μελέτες & νέες τεχνολογίες στην αναζωογόνηση CAAM Study Μαρία Δρακοπούλου Α’ Καρδιολογική Κλινική Ιπποκράτειο Νοσοκομείο

2. Aim To improve the management of patients in cardiac arrest, and this by comparing two initial airway management methods: Tracheal intubation and bag-valve-mask ventilation

3. European Resuscitation Council Guidelines J. Soar et al. / Resuscitation 95 (2015) 100–147

4. Hypothesis • Basic airway management (i.e. bag-valve-mask ventilation) is safe and may avoid the deleterious effects of tracheal intubation including interruption of chest compressions Question • Is bag-mask ventilation noninferior to endotracheal intubation for initial airway management during advanced resuscitation of patients with out-of-hospital cardiac arrest? Jabre P et al, JAMA. 2018 Feb 27;319(8):779-78

5. Association of Prehospital Advanced Airway Management With Neurologic Outcome and Survival in Patients WithOut-of-Hospital Cardiac Arrest A large Japanese observational study of 649 359 patients demonstrated a significant decrease in favorable functional survival associated with tracheal intubation vs ventilation by bag mask (1.1% vs 2.9%). Hasegawa K et al, JAMA. 2013 Jan 16;309(3):257-66

6. Advanced Cardiac Life Support in Out-of-Hospital Cardiac Arrest The addition of ALS interventions did not improve the rate of survival after out-of-hospital CA Stiellet,alN Engl J Med 2004;351:647-56

7. The association between timing of tracheal intubation and outcomes of adult in-hospital cardiac arrest: A retrospective cohort study Logit (p), where p represented the probability for favorable neurological outcome, and time to intubation Chih-Hung Wang et al, Resuscitation 105 (2016) 59–65

8. Airway management and out-of-hospital cardiac arrest outcome in the CARES registry Survival was higher among OHCA receiving ETI • Termination of resuscitation occurred in approximately 30% of patients and was least frequent in the ETI group • Unadjusted outcomes were highest for patients who did not receive successful advanced airway placement. Compared with those receiving successful SGA placement, unadjusted outcomes were better with ETI. McMullan et al, Resuscitation 85 (2014) 617–622

9. Study Setting • 20 pre-hospital emergency medical services centers(ambulance base stations equipped with 1 or more mobile intensive care units, consisting of an ambulance driver, a nurse, and an emergency physician as the minimum team) • 15 in France and 5 in Belgium. 3/2015 – 3/2017 (22months enrollment) • 1000 patients per arm is required to have 80% power to demonstrate non-inferiority with margin fixed at 1%

10. Study Population Inclusion criteria • Adults≥18 years old with OHCA who received resuscitation performed by clinicians from participating centers Exclusion criteria • Suspected massive aspiration before resuscitation, • Presence of a DNR order, • Known pregnancy, and/or • Imprisonment

11. Study Intervention • Out-of-Hospital Period (time of randomization- hospital admission): • Spontaneous circulation intubation in the out-of-hospital setting • If standard BMV was impossible ETI as a rescue procedure • In instances where the primary rescuers (ie, firefighters) arrived at the scene before the medical team ventilation with the bag mask was performed as part of basic life support. Patients were resuscitated according to international recommendations: a chest compression to breath ratio of 30:2 before ETI attempt and attention to ensure continuous compressions Patients were transported to the hospital only if they were successfully resuscitated at the scene

12. Study Intervention • In-hospital Period (time of hospital admission - hospital discharge): • No procedures or treatments relevant to the research protocol occurred during hospitalization. • If the patient’s condition improved during hospitalization, the investigator was required to inform the patient about his or her enrollment in the study. • Data collected during this period were death from any cause and vital status at day 28

13. Outcomes • Primary end point: survival at day 28 with favorable neurological function (Glasgow-Pittsburgh Cerebral Performance Categories (CPCs) of≤ 2 or less • Secondary study end points:rate of survival to hospital admission, rate of survival at 28 days, rate of ROSC, intubation difficulty assessed by the Intubation Difficulty Scale score, difficult intubation (defined by Intubation Difficulty Scale score >5), BMV difficulty assessed by a visual analog scale ranging from 0 mm to 100 mm and by the Han mask ventilation classification, and rate of BMV or ETI failure.

14. Flow Chart of Patient Inclusion Jabre P et al, JAMA. 2018 Feb 27;319(8):779-78

15. Baseline Characteristics

16. Primary outcome (ITT analysis) The lower limit of the confidence interval was greater than the threshold of noninferiority, thus noninferiority was not demonstrated Jabre P et al, JAMA. 2018 Feb 27;319(8):779-78

17. Secondary outcomes

18. Airway management adverse events analysis

19. Limitations • The use of ETI in the BMV group either after ROSC or when difficulty with airway management was encountered may question the BMV-only strategy in the intervention group. • This trial did not include comparison of inpatient management after cardiac arrest.

20. Conclusion • Patients with out of hospital CA, the use of BMV compared with ETI failed to demonstrate noninferiority or inferiority for survival with favorable 28-day neurological function, an inconclusive result. • The authors conclude that a “determination of equivalence or superiority between these techniques requires further research.”. On the other hand, BMV is associated with increased complications and difficulty. • Although this trial was hampered by sample size limitations, these data could prove useful for other investigators in designing future trials tomore definitively address the relative efficacy of BMV vs ETI for adults with out-of-hospital cardiac arrest

21. Discussion • Even if BMV were an equivalent strategy to ETI, BMV would be the preferred strategy due to greater ease in implementation and training. • Considerations regarding: training burden associated with ETI equipment costs, maintenance of skills, and the potential for unrecognized complications