Defibtech DDU-100 - Methods; Results; Conclusion

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DAC-510E-EN-BF
8.1.6.2 Methods
AEDswereprospectivelyrandomizedaccordingtodebrillationwaveformonadailybasisinfour
emergency medical services systems. First responders used either the 150-J biphasic AEDs or 200- to
360-J monophasic waveform AEDs on victims where defibrillation was indicated. A sequence of up to
three defibrillation shocks was delivered: 150J-150J-150J for the biphasic units and 200J-200J-360J for
the monophasic units. Defibrillation was defined as termination of VF for > 5 seconds, without regard to
hemodynamic factors.
8.1.6.3 Results
Of 338 patients with an out-of-hospital cardiac arrest, 115 had a cardiac etiology, presented with
ventricularbrillation,andwereshockedwithoneoftherandomizedAEDs.Therewerenostatistical
differences between the monophasic and biphasic groups in terms of age, sex, weight, primary structural
heart diseases, cause or location of arrest, bystanders who witnessed the arrest, or type of responder. A
summary of the results is presented in table below.
Biphasic Patients
Number (%)
Monophasic Patients
Number (%)
P Value
Defibrillation Efficacy:
1 shock
< 2 shocks
< 3 shocks
52/54 (96%)
52/54 (96%)
53/54 (98%)
36/61 (59%)
39/61 (64%)
42/61 (69%)
< 0.0001
< 0.0001
< 0.0001
Patientsdebrillated 54/54 (100%) 49/58 (84%) 0.003
ROSC 41/54 (76%) 33/61 (54%) 0.01
Survival to Hospital Admission 33/54 (61%) 31/61 (51%) 0.27
Survival to Hospital Discharge 15/54 (28%) 19/61 (31%) 0.69
8.1.6.4 Conclusion
More patients were defibrillated with an initial biphasic shock than monophasic shock and ultimately the
biphasic waveform defibrillated at higher rates than the monophasic waveform. A higher percentage of
patientsachievedReturnOfSpontaneousCirculation(“ROSC”)afterbiphasicshocks.Ratesofsurvivalto
hospital admission and discharge did not statistically differ between the two waveforms.