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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurophysiological Prognosis | Diagnostic Test | SEP and EEG evaluation for Neurological Prognosis of Cardiac Arrest | ||
| Multimodal Prognosis for poor early neurological outcome | Diagnostic Test | Brain CT, SEP and EEG evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Performance Categories | Neurological outcome will be the primary outcome measure and it will be assessed at 6 months after CA using CPC as follows: CPC 1, no or minor neurological deficits; CPC 2, moderate disability; CPC 3, severe disability; CPC 4, unresponsive wakefulness state and CPC 5, death. Neurological outcome will be dichotomized into 'good' (CPC 1-3) and 'poor' (CPC 4-5) outcomes | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalography, EEG | American Clinical Neurophysiology Society (ACNS) EEG terminology | hour: 12-24-72 |
| Somatosensory Evoked Potentials, SEP | According to the cortical responses of each hemisphere |
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Inclusion Criteria:
Exclusion Criteria:
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Every major patient after CA admitted to the follow intensive care unit: Careggi University Hospital (Firenze), which will be the coordinating center, San Giuseppe Hospital (Empoli), Bufalini Hospital (Cesena), Santa Maria delle Croci Hospital (Ravenna), Santa Maria NuovaHospital (Reggio Emilia), Ospedale Civile of Baggiovara (Baggiovara-Modena),Maggiore Hospital of Lodi (Lodi-Milano),San Raffaele Hospital (Milano), Ospedale Civile of Legnano (Legnano-Milano), Policlinico Umberto Primo (Roma), Santa Maria della Misericordia Hospital (Perugia), San Salvatore Hospital (L'Aquila), Galliera Hospital (Genova)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Careggi | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36375653 | Derived | Scarpino M, Lolli F, Lanzo G, Carrai R, Spalletti M, Valzania F, Lombardi M, Audenino D, Contardi S, Grazia Celani M, Marrelli A, Mecarelli O, Minardi C, Minicucci F, Politini L, Vitelli E, Peris A, Amantini A, Grippo A, Sandroni C; ProNeCA Study Group. Do changes in SSEP amplitude over time predict the outcome of comatose survivors of cardiac arrest? Resuscitation. 2022 Dec;181:133-139. doi: 10.1016/j.resuscitation.2022.10.025. Epub 2022 Nov 12. |
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| hour: 12-24-72 |
| Brain CT | Caudate nucleus(CN), putamen(PU) and posterior limb of the internal capsule(PIC) were bilaterally identified as circular (0.6cm2) regions of interest(ROIs) where density measurement (Hounsfield Units-HU) were performed. At the corpus callosum(CC) level, the density value was considered the same bilaterally. The GM/WM ratio at basal ganglia level was calculated as follows: GM/WM ratio= (CN+PU)/(CC+PIC) | within 24 hours |