Frequency of All Serious Adverse Events by Body System and Preferred TermĮTable 14. Sensitivity Analysis – Switching Patients Between Groups per Actual Treatment Received (Per Protocol Analysis)ĮTable 13. Sensitivity Analysis – Treating Patients with Missing Assessments as All Positive or 25 All NegativeĮTable 12. Logistic Regression and Covariate Adjustment for DeliriumĮTable 11. Reasons CAM or CAM-ICU Assessments Were Not ConductedĮTable 10. Number of Delirium Assessments CompletedĮTable 9. Intraoperative Mean Arterial Pressure (MAP) and Heart RateĮTable 8. Intraoperative Drug AdministrationĮTable 7. Patient Sociodemographic Characteristics and Pre-Operative Health Conditions by 30-16 day follow-up ResponseĮTable 6. Pre-Operative Health Conditions: ComorbiditiesĮTable 3. Patient Sociodemographic CharacteristicsĮTable 2. List of investigators and committees in the ENGAGES TrialĮTable 1. These comparisons between the groups were assessed with the Mann-Whitney U test. The overall median differences between the randomization groups in times with EEG suppression (7 minutes in the guided group and 13 in the usual care group difference, 6 minutes ) and BIS <40 (32 minutes in the guided group and 60 in the usual care group difference, 28 minutes ) were significant ( P < .001). BIS <40 data are shown for 594 of 604 patients (98.3%) in the guided group and 575 of 609 (94.4%) in the usual care group. Of the 1213 patients who were assessed for delirium, EEG suppression ratio data are shown for 595 of 604 patients (98.5%) in the guided group and 594 of 609 (97.5%) in the usual care group. In a few cases, the EEG suppression ratio or BIS data were not stored in the electronic health record. In some cases, these data were missing because of technical difficulties with the BIS equipment.
Suppression ratio and BIS data were excluded when the EEG signal quality index was <50. There was no imputation of missing suppression ratio or BIS data. The suppression time plots depict the cumulative times in each of the study groups during which the electroencephalogram suppression ratio was >1%. The box-and-whisker plots show the medians (thick horizontal lines) and interquartile ranges (IQRs boundaries of the box) and ranges.
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