Neurological Prognosis Cardiac Arrest Clinical Trial
Official title:
EEG and SEP Evaluation for Good and Poor Neurological Prognosis After Cardiac Arrest: a Prospective Multicenter Cohort Trial (proNeCA)
Hypoxic-Ischemic-encephalopathy (HIE) is a severe and frequent neurological complication of successful cardiopulmonary-resuscitation after cardiac arrest (CA). Prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power of the association between instrumental tests and, in addition, most of them were monocentric, retrospective and evaluating only poor outcome.
Post-anoxic encephalopathy is a severe and frequent neurological complication of successful
cardiopulmonary resuscitation and it is usually responsible for coma onset in patients
surviving a CA. A reliable early assessment of the neurological prognosis is an important
research goal because it could address CA patient management within intensive care units
(ICUs).
However, prognosticating neurological outcomes in patients with HIE is challenging and recent
guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power
of the association between instrumental tests and, in addition, most of them were
monocentric, retrospective and evaluating only poor outcome.
Thus, the investigators designed a multicenter prospective cohort study to assessing the
prognostic power of the association of electroencephalogram(EEG) and somatosensory evoked
potentials(SEPs) for the prediction of both poor and good neurological outcomes at different
times after CA.
The principal aim of this study will be to evaluate the prognostic power of EEG performed in
comatose patients within the first 12h after CA for good outcome prediction (cerebral
performance categories CPC 1-2-3) and to evaluate its prognostic power for the poor outcome
prediction (CPC 4-5) when performed at 24 and 72h after CA.
Moreover, the investigators will aim to evaluate if the combination of EEG and SEPs will
allow to correctly identify a greater number of patients with both poor and good outcomes
(when performed within the first 12h) and with poor outcomes (when performed after 72h)
compared with the use of only a single test. In addition, the investigators will evaluate if
the concordance of EEG/SEP patterns will increase the prognostic reliability obtained with a
single test.
Finally, the investigators will aim to confirm if the prognostic power of the bilaterally
absent(AA) SEP pattern for poor outcome prediction will be reliable at any time of recording
after CA, and if other SEP pathological patterns will assume an analogous ominous prognostic
significance.
ADDENDUM: after the conclusion of the enrollment we investigated the availability of brain CT
data obtained within the first 24 hours after CA. In 7 over 13 centers, including the
coordinator center (AOU Careggi, Florence) early brain CT data were available.
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