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Completed

NCT Number: NCT05042804

Perioperative Outcome Risk Assessment With Computer Learning Enhancement

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.

Completed

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Key information

Conditions

Morality Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Machine learning models predicting postoperative death and acute kidney injury

Other

The machine learning display uses data from the electronic health record to predict the likelihood of postoperative death and postoperative acute kidney injury.

Primary outcomes

  1. Area under receiver-operating characteristic curve of clinician prediction for postoperative death

    Time frame: 30 days

    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.

  2. Area under receiver-operating characteristic curve of clinician prediction for postoperative acute kidney injury

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Foundation for Anesthesia Education and Research

Registry information

Acronym: ORACLE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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