Clinical trial NCT06519890: Stanford ICU Delirium PIPRA Study
Official title: Stanford-PIPRA Study: The Accuracy of the Pre-Interventional Preventive Risk Assessment (PIPRA) Tool for the Prediction of ICU-Delirium in a Mixed Cardiothoracic Intensive Care Unit Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Cognitive Impairment
Delirium, Postoperative
Keywords: Artificial Intelligence
Delirium
Delirium Risk Factors
Cognitive Impairment
Postoperative Delirium
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stanford Hospital patients requiring admission to the Cardiothoracic ICU

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.

Eligibility criteria: 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)

4. 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

Primary outcomes:
measure: Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool
timeFrame: Detection of delirium presenting up to 30 days post-ICU admission
measure: Development of post-operative Delirium
timeFrame: Up to 30 days post-ICU admission
measure: Development of ICU Delirium
timeFrame: Up to 30 days post-ICU admission
measure: Determination of Delirium Phenotype
timeFrame: Up to 30 days post-ICU admission
measure: Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium.
timeFrame: Baseline measurement of variables and detection of delirium presenting up to 30 days post-ICU admission
measure: Receiver operating characteristic (ROC) curve analysis of PIPRA tool
timeFrame: Baseline measurement of variables and detection of delirium presenting up to 30 days post-ICU admission
Secondary outcomes:
measure: Immediate Postoperative Mortality
timeFrame: From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.
measure: Immediate post-ICU admission Mortality
timeFrame: From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.
measure: Length of ICU & Hospital Stay
timeFrame: 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)
measure: Discharge Site
timeFrame: Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)
measure: Requirement of Intensive Care Unit Admission
timeFrame: Time to discharge from the hospital (assessed up to 6 months from admission)
measure: Need of pharmacological protocol
timeFrame: From date of ICU admission up to time of discharge from the ICU (assessed up to 6 months from admission)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Jose R Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchan TA, Sadeghirad B, Schmutz N, Goettel N, Foroutan F, Couban R, Mbuagbaw L, Dodsworth BT. Preoperative prognostic factors associated with postoperative delirium in older people undergoing surgery: protocol for a systematic review and individual patient data meta-analysis. Syst Rev. 2020 Nov 14;9(1):261. doi: 10.1186/s13643-020-01518-z.
citation: Dodsworth BT, Reeve K, Falco L, Hueting T, Sadeghirad B, Mbuagbaw L, Goettel N, Schmutz Gelsomino N. Development and validation of an international preoperative risk assessment model for postoperative delirium. Age Ageing. 2023 Jun 1;52(6):afad086. doi: 10.1093/ageing/afad086.
citation: Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.
citation: Maldonado JR. Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium. Crit Care Clin. 2017 Jul;33(3):461-519. doi: 10.1016/j.ccc.2017.03.013.
citation: Robinson TN, Eiseman B. Postoperative delirium in the elderly: diagnosis and management. Clin Interv Aging. 2008;3(2):351-5. doi: 10.2147/cia.s2759.