Stanford ICU Delirium PIPRA Study
NCT Number: NCT06519890
Acronym: SIDPVS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Delirium|Cognitive Impairment|Delirium, Postoperative
Sponsor: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 199
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-30
Completion Date: 2024-07-27
Locations: Stanford Medical Center, Palo Alto, California, 94304, United States

Summary:
The purpose of this study is to determine the accuracy of the Pre-Interventional Preventive Risk Assessment (PIPRA) tool in predicting clinical cases of Intensive Care Units (ICU)-delirium, in a population at high risk of developing this syndrome (i.e., admitted patients to Cardiothoracic Intensive Care Units). The population to be studied has already been enrolled in a parallel study intended to determine the accuracy of an electroencephalogram (EEG)-based diagnosis for delirium.

Primary Outcome Measures: Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool, Assessment of the accuracy on the prediction of subjects identified as developing delirium by the PIPRA tool, as compared with post-operative standardized delirium assessment tools. We will compare the assessment of the PIPRA prediction tool (performed pre-op) with the actual development of delirium as assessed by a clinical assessment based on DSM; the CAM-ICU \& SPTD assessment tools., Detection of delirium presenting up to 30 days post-ICU admission|Development of post-operative Delirium, Number of subjects diagnosed with post-operative delirium, Up to 30 days post-ICU admission|Development of ICU Delirium, Number of subjects diagnosed with ICU delirium, Up to 30 days post-ICU admission|Determination of Delirium Phenotype, For those who develop delirium, the phenotype of delirium will be determined as per the Liptzin-Levkoff Criteria (based on DSM diagnostic Criteria). As such, all delirium episodes will be categorized as: hyperactive, hypoactive, mixed, or subsyndromal delirium., Up to 30 days post-ICU admission|Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium., Sensitivity and specificity of various cut off points of the PIPRA tool for detecting delirium., Baseline measurement of variables and detection of delirium presenting up to 30 days post-ICU admission|Receiver operating characteristic (ROC) curve analysis of PIPRA tool, Receiver operating characteristic (ROC) curve analysis of PIPRA tool, Baseline measurement of variables and detection of delirium presenting up to 30 days post-ICU admission
Secondary Outcome Measures: Immediate Postoperative Mortality, Mortality rate immediately after index surgery, From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.|Immediate post-ICU admission Mortality, Mortality rate following ICU admission, From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.|Length of ICU & Hospital Stay, Total number of days admitted to the hospital, From date of ICU admission up to time of discharge from the ICU, and then from the hospital (assessed up to 1 year after admission)|Discharge Site, Site of discharge (e.g., home, rehabilitation, skilled nurse facility, etc), Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)|Requirement of Intensive Care Unit Admission, Need for admission to an intensive care unit due to clinical necessity or deterioration, Time to discharge from the hospital (assessed up to 6 months from admission)|Need of pharmacological protocol, Need of pharmacological agents required for the management of delirium, From date of ICU admission up to time of discharge from the ICU (assessed up to 6 months from admission)