Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567574
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Stanford PIPRA Validation Study in an Elderly Orthopedic Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Stanford Study of the Validation of the Pre-Interventional Preventive Risk Assessment PIPRA Tool In The At-Risk Orthopedic Surgery Population
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPRA-ORTHO
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 ie 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 ID55169 David Drover-Principal investigator José Maldonado-Co-investigator
Detailed Description:
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 patients risk for developing delirium as part of the riskbenefit 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 patients electronic medical record EMR The tool has been designed to run in the background of the EMR and automatically calculate the patients 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 heightweight 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
The PIPRA tools consists of nine items commonly found in any presurgical patients electronic medical record EMR The tool has been designed to run in the background of the EMR and automatically calculate the patients 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 heightweight 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None