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Completed

NCT Number: NCT06567574

Stanford PIPRA Validation Study in an Elderly Orthopedic Population

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]).

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Key information

Conditions

Delirium Cognition Disorders Cognitive Dysfunction Cognitive Impairment Confusion Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Medical Center

Palo Alto, California, 94304, United States

About this study

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 post-operative delirium (POD) 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 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 our study, we 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 POD 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 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 POD following surgery.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool

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

    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.

  2. Development of post-operative Delirium

    Time frame: Up to 72 hours post-operatively

    Number of subjects diagnosed with post-operative delirium

  3. Determination of Delirium Phenotype

    Time frame: Up to 72 hours post-operatively.

    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.

  4. Impact of delirium on post-operative cognitive impairment

    Time frame: Up to 10-year post-operatively.

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

  5. Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium.

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

    Sensitivity and specificity of various cut off points of the PIPRA tool for detecting postoperative delirium.

  6. Receiver operating characteristic (ROC) curve analysis of PIPRA tool

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

    Receiver operating characteristic (ROC) curve analysis of PIPRA tool

Secondary outcomes

  1. Immediate Postoperative Mortality

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

    Mortality rate immediately after index surgery

  2. Length of Hospital Length of Stay

    Time frame: From date of post-operative admission up to time of postoperative discharge (assessed up to 1 year after admission).

    Total number of days admitted to the hospital

  3. Discharge Site

    Time frame: 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)

  4. Requirement of Intensive Care Unit Admission

    Time frame: 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

  5. Need of pharmacological protocol

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

    Need of pharmacological protocol for management of delirium

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Stanford Study of the Validation of the Pre-Interventional Preventive Risk Assessment (PIPRA) Tool In The At-Risk Orthopedic Surgery Population

Acronym: PIPRA-ORTHO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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