Stanford Study of the Validation of the Pre-Interventional Preventive Risk Assessment (PIPRA) Tool In The At-Risk Orthopedic Surgery Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool
研究概览
简要总结
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]).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgical patients
- •Greater than or equal to 65 years old
- •ASA I, II or III
- •Greater than 90 min of surgery
- •Non-cardiac surgery
排除标准
- •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
结局指标
主要结局
Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool
时间窗: 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.
Receiver operating characteristic (ROC) curve analysis of PIPRA tool
时间窗: Baseline measurement of variables and detection of delirium presenting up to 72 hours post-operatively
Receiver operating characteristic (ROC) curve analysis of PIPRA tool
Development of post-operative Delirium
时间窗: Up to 72 hours post-operatively
Number of subjects diagnosed with post-operative delirium
Determination of Delirium Phenotype
时间窗: 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.
Impact of delirium on post-operative cognitive impairment
时间窗: Up to 10-year post-operatively.
Impact of delirium occurrence and emergence of cognitive impairment post-operatively
Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium.
时间窗: 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.
次要结局
- 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))
- Discharge Site(Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission))
- 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).)
研究者
Jose R Maldonado, MD
Professor of Medicine and Psychiatry
Stanford University