EEG and SEP Evaluation for Good and Poor Neurological Prognosis After Cardiac Arrest
Condition: Neurological Prognosis Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Neurophysiological Prognosis; Multimodal Prognosis for poor early neurological outcome
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): SEP and EEG evaluation for Neurological Prognosis of Cardiac Arrest; Brain CT, SEP and EEG evaluation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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)