NCT05270603

The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)

Comparing the Reliability of a Web-based Intraoperative Adverse Event Assessment Tool With Standard Cognitive Grading. The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of intraoperative adverse events (iAEs). Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the 5 published iAE grading systems. We plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications. The purpose of this study is two-fold. First, the investigators hope to evaluate the utility of a web-based intraoperative adverse event (iAE) grading system known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) calculator. Second, the investigators plan to evaluate the difference in iAE grading outcomes of the ICARUS calculator compared with standard iAE grading.

Detailed description

Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. Without consistent and homogenous reporting, these events represent a substantial gap in contemporary surgical literature and clinical practice. By definition, an iAE is any unplanned incident related to a surgical intervention occurring between skin incision and skin closure. Despite the availability of multiple intraoperative grading and classification systems, colloquiallary known as: EAUiaiC, iAE severity classification scheme, Modified Satava, EAES Grading system, and ClassIntra® (formerly CLASSIC) , the reporting of intraoperative adverse events remains exceedingly rare. Further, while most studies report postoperative adverse events, only a fraction of surgical publications report intraoperative complications as outcomes of interest. As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of iAEs. Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the four aforementioned iAE grading systems. The investigators plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.

Conditions

• Intraoperative Complications
• Surgery--Complications
• Surgery
• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
OTHER	ICARUS intraoperative adverse events calculator	The ICARUS calculator is a web-based tool that uses answers to Boolean, yes/no questions to determine the iAE grade (appendix I). The calculator providers iAE grade outputs for the 5 iAE classification systems. https://garnmile.com/iaecalc/ Development of the ICARUS calculator was performed as follows: Referencing the 5 classification systems, we first assembled a list of Boolean questions based on the iAE grade descriptions. This list was distilled to the minimum number of questions necessary to represent all descriptions in the combined list of iAE grades. Next, these questions were used to independently establish the conditional logic required to determine iAE grade for each classification system. The questions and logic were translated into Hypertext Preprocessor (PHP), a server-side programming language, and JavaScript, a client-side scripting language.

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-04-15
• Completion: 2022-06-01
• First posted: 2022-03-08
• Last updated: 2022-05-05

Locations

1 site across 1 country: United States