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

University of Southern California

Status: Unknown

Conditions: Intraoperative Complications; Surgical Procedure, Unspecified; Surgery; Surgery--Complications

Treatments: Other: ICARUS intraoperative adverse events calculator

Study type: Observational

Funder types: Other

Identifiers

NCT05270603

UP-21-01010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Documented understanding, willingness, and agreement to participate in this study
• Males and females; age 18 or older
• Must be either English speaking or fluent with English medical terminology
• Currently or formerly practicing surgeon or proceduralist, regardless of the domain

Exclusion criteria

• Activity restrictions that limit one's ability to engage in online survey
• Adults not competent to consent
• Minors, human fetuses, neonates Prisoners/Detainees

Trial design

2,000 participants in 2 patient groups

ICARUS Calculator Raters (Intervention Group)

Description:

Surgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems

Treatment:

Other: ICARUS intraoperative adverse events calculator

Cognitive Grading Raters (Control Group)

Description:

Surgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios (same as the Intervention group) selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems

Treatment:

Other: ICARUS intraoperative adverse events calculator