Perioperative Outcome Risk Assessment With Computer Learning Enhancement

Acute Kidney Injury Clinical Trial

— ORACLE  

Official title:

Perioperative Outcome Risk Assessment With Computer Learning Enhancement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042804
• Other study ID #: 202108022
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test whether anesthesiology clinicians working in a telemedicine setting can predict patient risk for postoperative complications (death and acute kidney injury) more accurately with access to a machine learning display than without it.

Description:

The Perioperative Outcome Risk Assessment with Computer Learning Enhancement (Periop ORACLE) study will be a sub-study nested within the ongoing TECTONICS trial (NCT03923699). TECTONICS is a single-center randomized clinical trial assessing the impact of an anesthesiology control tower (ACT) on postoperative 30-day mortality, delirium, respiratory failure, and acute kidney injury. As part of the TECTONICS trial, investigators in the ACT perform medical record case reviews during the early part of surgery and document how likely they feel each patient is to experience postoperative death and acute kidney injury (AKI). In Periop ORACLE, these case reviews will be randomized to be performed with or without access to machine learning (ML) predictions.

Investigators in the ACT will conduct all case reviews by viewing the patient's records in AlertWatch (AlertWatch, Ann Arbor, MI) and Epic (Epic, Verona, WI). AlertWatch is an FDA-approved patient monitoring system designed for use in the operating room. The version of AlertWatch used in this study has been customized for use in a telemedicine setting. Epic is the electronic health record system utilized at Barnes-Jewish Hospital. Each case review will be randomized in a 1:1 fashion to be completed with or without ML assistance. If the case review is randomized to ML assistance, the investigator will access a display interface (currently deployed as a web application on a secure server) that shows real-time ML predicted likelihood for postoperative death and postoperative AKI. If the case review is not randomized to ML assistance, the investigator will not access this display. After viewing the patient's data, the investigator will predict how likely the patient is to experience postoperative death and postoperative AKI and will document this prediction. The area under the receiver operating characteristic curves for predictions made with ML assistance and without ML assistance will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5114
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgery in the main operating suite at Barnes-Jewish Hospital

• Surgery during hours of ACT operation (weekdays 7:00am-4:00pm)

• Enrolled in the TECTONICS randomized clinical trial (NCT03923699)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Kidney Injury
• Morality

Intervention

Other:
• Machine learning models predicting postoperative death and acute kidney injury
The machine learning display uses data from the electronic health record to predict the likelihood of postoperative death and postoperative acute kidney injury.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Foundation for Anesthesia Education and Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under receiver-operating characteristic curve of clinician prediction for postoperative death	Clinicians will predict the likelihood of postoperative death for each case using a categorical scale. A logistic regression will be constructed using the clinician predictions as inputs, and the area under the receiver-operating characteristic curve will be determined.	30 days
Primary	Area under receiver-operating characteristic curve of clinician prediction for postoperative acute kidney injury	Clinicians will predict the likelihood of postoperative acute kidney injury for each case using a categorical scale. A logistic regression will be constructed using the clinician predictions as inputs, and the area under the receiver-operating characteristic curve will be determined.	7 days