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

• Conditions: Surgery--Complications; Intraoperative Complications; Surgical Procedure, Unspecified; Surgery
• Interventions: Other: ICARUS intraoperative adverse events calculator

• Registration Number: NCT05270603
• Lead Sponsor: University of Southern California

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Study Start: 2022-03-15
• Primary Completion: 2022-04-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICARUS Calculator Raters (Intervention Group)	ICARUS intraoperative adverse events calculator	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
Cognitive Grading Raters (Control Group)	ICARUS intraoperative adverse events calculator	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

Primary Outcome Measures

Name	Time	Method
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade	03-01-2022 to 03-15-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades	03-01-2022 to 03-15-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Evaluate theTime to complete grading (minutes) using the 5 iAEs grading systems	03-01-2022 to 03-15-2022	Primary data analysis will involve calculations i to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Time to complete grading (minutes)
Evaluate Time to complete grading (minutes)using the ICARUS Calculator	03-16-2022- to 06-01-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Time to complete grading (minutes)
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in term of Distribution of responses by count and percent	03-16-2022- to 06-01-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Distribution of responses by count and percent
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent	03-01-2022 to 03-15-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Distribution of responses by count and percent
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Cohen's Kappa	03-16-2022- to 06-01-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Cohen's Kappa	03-01-2022 to 03-15-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in terms of Percent agreement of grade	03-16-2022- to 06-01-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade
Determination of benefit in efficiency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	03-16-2022- to 06-01-2022	Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events; There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC; 2. ICARUS calculator vs. iAE severity; 3. ICARUS calculator vs. Modified Satava; 4. ICARUS calculator vs. ClassIntra; 5. ICARUS calculator vs. EAES Classification
Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	03-16-2022- to 06-01-2022	Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events; There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC; 2. ICARUS calculator vs. iAE severity; 3. ICARUS calculator vs. Modified Satava; 4. ICARUS calculator vs. ClassIntra; 5. ICARUS calculator vs. EAES Classification
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades	03-16-2022- to 06-01-2022	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	03-16-2022- to 06-01-2022	Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events; There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC; 2. ICARUS calculator vs. iAE severity; 3. ICARUS calculator vs. Modified Satava; 4. ICARUS calculator vs. ClassIntra; 5. ICARUS calculator vs. EAES Classification
Determination of benefit in inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	03-16-2022- to 06-01-2022	Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events; There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC; 2. ICARUS calculator vs. iAE severity; 3. ICARUS calculator vs. Modified Satava; 4. ICARUS calculator vs. ClassIntra; 5. ICARUS calculator vs. EAES Classification

Secondary Outcome Measures

Name	Time	Method
Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire.	03-16-2022- to 06-01-2022	Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS) and Usefulness, Satisfaction and Ease of Use (USE) questionnaire
Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS)	03-16-2022- to 06-01-2022	Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS)
Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire	03-16-2022- to 06-01-2022	Assess the physician satisfaction using a validated questionnaires System Usability Scale (SUS) questionnaire

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States