Stanford ICU Delirium PIPRA Study

Completed

• Conditions: Cognitive Impairment; Delirium, Postoperative; Delirium

• Registration Number: NCT06519890
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Study investigators would like to determine the real-life accuracy of a new tool developed for the prediction of delirium: Pre-Interventional Preventive Risk Assessment (PIPRA) Tool. The importance of assessing the risk for delirium includes: providing clinicians and patients with accurate predictive information regarding the patient's risk for developing delirium as part of the risk/benefit calculation for surgical procedures and/or admission to an intensive care unit (ICU), and thus potential risk of subsequent cognitive impairment; as well as the ability to introduce timely prophylactic techniques that may prevent its onset.

The PIPRA tools consists of nine items commonly found in any presurgical patient's electronic medical record (EMR). The tool has been designed to run in the background of the EMR and automatically calculate the patient's risk for developing delirium upon admission for surgical intervention. For this study, study investigators will be applying the PIPRA tool to the EMR of patients already enrolled in a parallel study as detailed above.

The PIPRA tool predicts the risk of developing delirium based on its algorithm that takes into consideration the following nine clinical variables: age, height/weight or body mass index, the American Society of Anesthesiologist physical status Classification system (ASA), past history of delirium, past history of cognitive impairment (including dementia), number of medications, preoperative C-reactive protein (CRP) levels, surgical risk (as determined by the European Society of Anesthesiology), and type of surgery. The subsequent result predicts the risk (in percentage) of a patient developing delirium.

The PIPRA tool is fully integrated into EMR systems, operating in the background, extracting relevant information, and automatically generating a delirium prediction score. In addition, this software possesses the flexibility to recalibrate the delirium risk based on the availability of the nine clinical variables.

Study Timeline

• Study First Submitted: 2024-03-25
• Study Start: 2024-04-30
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Primary Completion: 2024-07-27
• Study Completion: 2024-07-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

1. Age is 18 years or older

2. Clinical suspicion of delirium or subject at risk for delirium 3. Admitted to the Intensive Care Unit (ICU)

3. Expected ICU stay is greater than one (1) day 5. Subject must be fluent in English

Exclusion Criteria

1. Age is younger than 18 years
2. Subjects with a primary neurological or neurosurgical condition such as stroke, epilepsy, brain tumor, or witnessed seizures, Parkinson's disease, traumatic brain injury, craniectomy, known severe dementia, or Central Nervous System (CNS) infection
3. Active CNS substance abuse, intoxication, or withdrawal
4. Unarousable or unresponsive subjects with Richmond Agitation Sedation Scale (RASS) <-3
5. Subject is blind, deaf, or unable to speak or understand English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of ICU Delirium	Up to 30 days post-ICU admission	Number of subjects diagnosed with ICU delirium
Development of post-operative Delirium	Up to 30 days post-ICU admission	Number of subjects diagnosed with post-operative delirium
Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium.	Baseline measurement of variables and detection of delirium presenting up to 30 days post-ICU admission	Sensitivity and specificity of various cut off points of the PIPRA tool for detecting delirium.
Determination of Delirium Phenotype	Up to 30 days post-ICU admission	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.
Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool	Detection of delirium presenting up to 30 days post-ICU admission	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.
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	Receiver operating characteristic (ROC) curve analysis of PIPRA tool

Secondary Outcome Measures

Name	Time	Method
Length of ICU & Hospital Stay	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)	Total number of days admitted to the hospital
Discharge Site	Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)	Site of discharge (e.g., home, rehabilitation, skilled nurse facility, etc)
Requirement of Intensive Care Unit Admission	Time to discharge from the hospital (assessed up to 6 months from admission)	Need for admission to an intensive care unit due to clinical necessity or deterioration
Need of pharmacological protocol	From date of ICU admission up to time of discharge from the ICU (assessed up to 6 months from admission)	Need of pharmacological agents required for the management of delirium
Immediate Postoperative Mortality	From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.	Mortality rate immediately after index surgery
Immediate post-ICU admission Mortality	From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.	Mortality rate following ICU admission

Trial Locations

Locations (1)

Stanford Medical Center; 🇺🇸 Palo Alto, California, United States