Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519890
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-03-25
Brief Title:
Stanford ICU Delirium PIPRA Study
Sponsor:
None
Organization:
None
Study Overview
Official 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
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:
SIDPVS
Brief Summary:
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 ie 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
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 delirium 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 andor 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 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 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 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 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
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 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 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 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
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