TY - JOUR
T1 - Prognostic accuracy of head computed tomography for prediction of functional outcome after out-of-hospital cardiac arrest
T2 - Rationale and design of the prospective TTM2-CT-substudy
AU - Lang, Margareta
AU - Leithner, Christoph
AU - Scheel, Michael
AU - Kenda, Martin
AU - Cronberg, Tobias
AU - During, Joachim
AU - Rylander, Christian
AU - Annborn, Martin
AU - Dankiewicz, Josef
AU - Deye, Nicolas
AU - Halliday, Thomas
AU - Lascarrou, Jean Baptiste
AU - Matthew, Thomas
AU - McGuigan, Peter
AU - Morgan, Matt
AU - Thomas, Matthew
AU - Ullén, Susann
AU - Undén, Johan
AU - Nielsen, Niklas
AU - Moseby-Knappe, Marion
PY - 2022
Y1 - 2022
N2 - Background: Head computed tomography (CT) is a guideline recommended method to predict functional outcome after cardiac arrest (CA), but standardized criteria for evaluation are lacking. To date, no prospective trial has systematically validated methods for diagnosing hypoxic-ischaemic encephalopathy (HIE) on CT after CA. We present a protocol for validation of pre-specified radiological criteria for assessment of HIE on CT for neuroprognostication after CA. Methods/design: This is a prospective observational international multicentre substudy of the Targeted Hypothermia versus Targeted Normothermia after out-of-hospital cardiac arrest (TTM2) trial. Patients still unconscious 48 hours post-arrest at 13 participating hospitals were routinely examined with CT. Original images will be evaluated by examiners blinded to clinical data using a standardized protocol. Qualitative assessment will include evaluation of absence/presence of “severe HIE”. Radiodensities will be quantified in pre-specified regions of interest for calculation of grey-white matter ratios (GWR) at the basal ganglia level. Functional outcome will be dichotomized into good (modified Rankin Scale 0–3) and poor (modified Rankin Scale 4–6) at six months post-arrest. Prognostic accuracies for good and poor outcome will be presented as sensitivities and specificities with 95% confidence intervals (using pre-specified cut-offs for quantitative analysis), descriptive statistics (Area Under the Receiver Operating Characteristics Curve), inter- and intra-rater reliabilities according to STARD guidelines. Conclusions: The results from this prospective trial will validate a standardized approach to radiological evaluations of HIE on CT for prediction of functional outcome in comatose CA patients. The TTM2 trial and the TTM2 CT substudy are registered at ClinicalTrials.gov NCT02908308 and NCT03913065.
AB - Background: Head computed tomography (CT) is a guideline recommended method to predict functional outcome after cardiac arrest (CA), but standardized criteria for evaluation are lacking. To date, no prospective trial has systematically validated methods for diagnosing hypoxic-ischaemic encephalopathy (HIE) on CT after CA. We present a protocol for validation of pre-specified radiological criteria for assessment of HIE on CT for neuroprognostication after CA. Methods/design: This is a prospective observational international multicentre substudy of the Targeted Hypothermia versus Targeted Normothermia after out-of-hospital cardiac arrest (TTM2) trial. Patients still unconscious 48 hours post-arrest at 13 participating hospitals were routinely examined with CT. Original images will be evaluated by examiners blinded to clinical data using a standardized protocol. Qualitative assessment will include evaluation of absence/presence of “severe HIE”. Radiodensities will be quantified in pre-specified regions of interest for calculation of grey-white matter ratios (GWR) at the basal ganglia level. Functional outcome will be dichotomized into good (modified Rankin Scale 0–3) and poor (modified Rankin Scale 4–6) at six months post-arrest. Prognostic accuracies for good and poor outcome will be presented as sensitivities and specificities with 95% confidence intervals (using pre-specified cut-offs for quantitative analysis), descriptive statistics (Area Under the Receiver Operating Characteristics Curve), inter- and intra-rater reliabilities according to STARD guidelines. Conclusions: The results from this prospective trial will validate a standardized approach to radiological evaluations of HIE on CT for prediction of functional outcome in comatose CA patients. The TTM2 trial and the TTM2 CT substudy are registered at ClinicalTrials.gov NCT02908308 and NCT03913065.
KW - Cardiac arrest
KW - Computed tomography
KW - GWR grey-white matter ratio
KW - Hypoxic-ischaemic encephalopathy (HIE)
KW - Neuroprognostication
KW - Outcome
KW - Targeted temperature management
U2 - 10.1016/j.resplu.2022.100316
DO - 10.1016/j.resplu.2022.100316
M3 - Article
C2 - 36267356
AN - SCOPUS:85140012278
SN - 2666-5204
VL - 12
JO - Resuscitation Plus
JF - Resuscitation Plus
M1 - 100316
ER -