Stanford ICU Delirium PIPRA Study

NCT06519890 | Completed

• 1 other identifier: IRB #74903
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Cognitive Impairment; Delirium, Postoperative

Keywords

Artificial Intelligence; Delirium; Delirium Risk Factors; Cognitive Impairment; Postoperative Delirium

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Immediate Postoperative Mortality

  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

  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

  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

  Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)

• Requirement of Intensive Care Unit Admission

  Time to discharge from the hospital (assessed up to 6 months from admission)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stanford Hospital patients requiring admission to the Cardiothoracic ICU

You may qualify if:

• Age is 18 years or older
• Clinical suspicion of delirium or subject at risk for delirium 3. Admitted to the Intensive Care Unit (ICU)
• \. Expected ICU stay is greater than one (1) day 5. Subject must be fluent in English

You may not qualify if:

• Age is younger than 18 years
• 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
• Active CNS substance abuse, intoxication, or withdrawal
• Unarousable or unresponsive subjects with Richmond Agitation Sedation Scale (RASS) \<-3
• Subject is blind, deaf, or unable to speak or understand English

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Medical Center

Palo Alto, California, 94304, United States

Location

Related Publications (5)

• 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.

  PMID: 33189147 RESULT

• 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.

  PMID: 37290122 RESULT

• 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.

  PMID: 37819663 RESULT

• 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.

  PMID: 28601132 RESULT

• 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.

  PMID: 18686756 RESULT

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Postoperative Complications; Pathologic Processes

Study Officials

• Jose R Maldonado, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Psychiatry

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: July 25, 2024
• Study Start: April 30, 2024
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)