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Completed

NCT Number: NCT06519890

Stanford ICU Delirium PIPRA Study

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.

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Key information

Conditions

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

Age range

18 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 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

  2. Development of post-operative Delirium

    Time frame: Up to 30 days post-ICU admission

    Number of subjects diagnosed with post-operative delirium

  3. Development of ICU Delirium

    Time frame: Up to 30 days post-ICU admission

    Number of subjects diagnosed with ICU delirium

  4. Determination of Delirium Phenotype

    Time frame: 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.

  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 30 days post-ICU admission

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

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

    Time frame: 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 outcomes

  1. Immediate Postoperative Mortality

    Time frame: 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

  2. Immediate post-ICU admission Mortality

    Time frame: 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

  3. Length of ICU & Hospital Stay

    Time frame: 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

  4. 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)

  5. 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

  6. Need of pharmacological protocol

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Acronym: SIDPVS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Aug 9, 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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