Stanford PIPRA Validation Study in an Elderly Orthopedic Population

NCT06567574 | Completed

• 1 other identifier: IRB-73341
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the accuracy of an AI-based tool in the prediction of postoperative delirium (POD), in a population at moderately high risk of developing this syndrome (i.e., elderly orthopedic subjects). The population to be studied has already been enrolled in a parallel study regarding the likelihood of developing delirium, its relationship to the type of anesthetic, and the relationship between anesthetic type, development of delirium and risk for post-operative cognitive impairment (including risk for dementia) (Protocol ID#55169 \[David Drover-Principal investigator; José Maldonado-Co-investigator\]).

Conditions

Delirium; Postoperative Delirium; Cognitive Impairment

Keywords

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

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.

  Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively

• Development of post-operative Delirium

  Number of subjects diagnosed with post-operative delirium

  Up to 72 hours post-operatively

• 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 72 hours post-operatively.

• Impact of delirium on post-operative cognitive impairment

  Impact of delirium occurrence and emergence of cognitive impairment post-operatively

  Up to 10-year post-operatively.

• 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 postoperative delirium.

  Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively

• 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 72 hours post-operatively

Secondary Outcomes (5)

• Immediate Postoperative Mortality

  From date of post-operative admission up to time of postoperative discharge, an average of 72 hours.

• Length of Hospital Length of Stay

  From date of post-operative admission up to time of postoperative discharge (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)

• Need of pharmacological protocol

  From post-operative hospital admission up to time of postoperative discharge (assessed up to 6 months from admission)

Eligibility Criteria

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

Study Population

Stanford Hospital geriatric patients having surgery

You may qualify if:

• Surgical patients
• Greater than or equal to 65 years old
• ASA I, II or III
• Greater than 90 min of surgery
• Non-cardiac surgery

You may not qualify if:

• Dementia
• Alzheimer's
• Parkinson's
• Current Benzodiazepine use
• Alcoholism
• Previous surgery within the last 12 months or expected in the 12 months to come (except the expected surgery for which they are being enrolled).
• Color-blindness

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; Emergence Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• José 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: August 20, 2024
• First Posted: August 22, 2024
• Study Start: April 30, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)