DeliriumSIDPVSNCT06519890
Stanford ICU Delirium PIPRA Study
An observational study of Delirium and Cognitive Impairment, run by Stanford University at 1 site in United States.
Trial 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 (i.e., admitted patients to Cardiothoracic Intensive Care Units). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Cognitive Impairment, Delirium, Postoperative
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 27 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stanford Hospital patients requiring admission to the Cardiothoracic ICU
Who may be able to join
- Age is 18 years or older
- Clinical suspicion of delirium or subject at risk for delirium 3. Admitted to the Intensive Care Unit (ICU)
- 4. Expected ICU stay is greater than one (1) day 5. Subject must be fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Medical Center
Palo Alto, California, 94304
About this study
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
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.
Read the 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 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.
- Conditions
- Delirium, Cognitive Impairment, Delirium, Postoperative
- Keywords
- Artificial Intelligence, Delirium, Delirium Risk Factors, Cognitive Impairment, Postoperative Delirium
- Medical subject headings
- Delirium, Cognitive Dysfunction, Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with postoperative delirium accurately predicted by the PIPRA Tool
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.
Measured: Detection of delirium presenting up to 30 days post-ICU admission
Development of post-operative Delirium
Number of subjects diagnosed with post-operative delirium
Measured: Up to 30 days post-ICU admission
Development of ICU Delirium
Number of subjects diagnosed with ICU delirium
Measured: Up to 30 days post-ICU admission
Determination of Delirium Phenotype
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.
Measured: Up to 30 days post-ICU admission
Sensitivity and specificity of the PIPRA tool for detecting postoperative delirium.
Sensitivity and specificity of various cut off points of the PIPRA tool for detecting delirium.
Measured: 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
Receiver operating characteristic (ROC) curve analysis of PIPRA tool
Measured: Baseline measurement of variables and detection of delirium presenting up to 30 days post-ICU admission
Secondary outcomes (6)
Immediate Postoperative Mortality
Mortality rate immediately after index surgery
Measured: From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.
Immediate post-ICU admission Mortality
Mortality rate following ICU admission
Measured: From date of ICU admission up to time of discharge from the Intensive Care Unit, an average of two weeks.
Length of ICU & Hospital Stay
Total number of days admitted to the hospital
Measured: 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)
Discharge Site
Site of discharge (e.g., home, rehabilitation, skilled nurse facility, etc)
Measured: Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)
Requirement of Intensive Care Unit Admission
Need for admission to an intensive care unit due to clinical necessity or deterioration
Measured: Time to discharge from the hospital (assessed up to 6 months from admission)
Need of pharmacological protocol
Need of pharmacological agents required for the management of delirium
Measured: From date of ICU admission up to time of discharge from the ICU (assessed up to 6 months from admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 Apr 2024
- Primary completion27 Jul 2024
- Study completion27 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose R Maldonado, MD, Stanford University
- Investigators
- Jose R Maldonado, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519890
- Sponsor's protocol ID
- IRB #74903
- Acronym
- SIDPVS
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchan TA, Sadeghirad B, Schmutz N, Goettel N, Foroutan F, Couban R, Mbuagbaw L, Dodsworth BT. Preoperative prognostic factors associated with postoperative delirium in older people undergoing surgery: protocol for a systematic review and individual patient data meta-analysis. Syst Rev. 2020 Nov 14;9(1):261. doi: 10.1186/s13643-020-01518-z.
PubMed 33189147Dodsworth BT, Reeve K, Falco L, Hueting T, Sadeghirad B, Mbuagbaw L, Goettel N, Schmutz Gelsomino N. Development and validation of an international preoperative risk assessment model for postoperative delirium. Age Ageing. 2023 Jun 1;52(6):afad086. doi: 10.1093/ageing/afad086.
PubMed 37290122Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.
PubMed 37819663Maldonado JR. Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium. Crit Care Clin. 2017 Jul;33(3):461-519. doi: 10.1016/j.ccc.2017.03.013.
PubMed 28601132Robinson TN, Eiseman B. Postoperative delirium in the elderly: diagnosis and management. Clin Interv Aging. 2008;3(2):351-5. doi: 10.2147/cia.s2759.
PubMed 18686756
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06519890
- Acronym / sponsor ID
- SIDPVS / IRB #74903
- Conditions
- Delirium, Cognitive Impairment, Delirium, Postoperative
- Keywords
- Artificial Intelligence, Delirium, Delirium Risk Factors, Cognitive Impairment, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stanford Hospital patients requiring admission to the Cardiothoracic ICU
Key inclusion criteria (3 listed)
- Age is 18 years or older
- Clinical suspicion of delirium or subject at risk for delirium 3. Admitted to the Intensive Care Unit (ICU)
- 4. Expected ICU stay is greater than one (1) day 5. Subject must be fluent in English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Development of post-operative Delirium
Time frame: Up to 30 days post-ICU admission
Number of subjects diagnosed with post-operative delirium
Development of ICU Delirium
Time frame: Up to 30 days post-ICU admission
Number of subjects diagnosed with ICU delirium
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.
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.
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
6 secondary outcomes
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.
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.
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)
Discharge Site
Time frame: Type of facility the patient was discharge to from the hospital (assessed up to 6 months from admission)
Requirement of Intensive Care Unit Admission
Time frame: Time to discharge from the hospital (assessed up to 6 months from admission)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 33189147Buchan TA, Sadeghirad B, Schmutz N, Goettel N, Foroutan F, Couban R, Mbuagbaw L, Dodsworth BT. Preoperative prognostic factors associated with postoperative delirium in older people undergoing surgery: protocol for a systematic review and individual patient data meta-analysis. Syst Rev. 2020 Nov 14;9(1):261. doi: 10.1186/s13643-020-01518-z.
- Results publication: PubMed 37290122Dodsworth BT, Reeve K, Falco L, Hueting T, Sadeghirad B, Mbuagbaw L, Goettel N, Schmutz Gelsomino N. Development and validation of an international preoperative risk assessment model for postoperative delirium. Age Ageing. 2023 Jun 1;52(6):afad086. doi: 10.1093/ageing/afad086.
- Results publication: PubMed 37819663Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.
- Results publication: PubMed 28601132Maldonado JR. Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium. Crit Care Clin. 2017 Jul;33(3):461-519. doi: 10.1016/j.ccc.2017.03.013.
- Results publication: PubMed 18686756Robinson TN, Eiseman B. Postoperative delirium in the elderly: diagnosis and management. Clin Interv Aging. 2008;3(2):351-5. doi: 10.2147/cia.s2759.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose R Maldonado, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Cognitive Impairment, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519890, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.