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

Surgery Clinical Trial

— ICARUS-C  

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05270603
• Other study ID #: UP-21-01010
• Status: Enrolling by invitation
• Start date: March 15, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: June 1, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (6)

Biyani CS, Pecanka J, Rouprêt M, Jensen JB, Mitropoulos D. Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel. Eur Urol. 2020 May;77(5):601-610. doi: 10.1016/j.eururo.2019.11.015. Epub 2019 Nov 29. — View Citation

Cacciamani G, Sholklapper T, Sotelo R, Desai M, Gill I. A Protocol for the Development of the Intraoperative Complications Assessment and Reporting With Universal Standards Criteria: The ICARUS Project. Int J Surg Protoc. 2021 Aug 6;25(1):160-164. doi: 10.29337/ijsp.155. eCollection 2021. — View Citation

Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gié O, Goebel B, Hahnloser D, Herbst F, Orestis I, Joller S, Kang S, Martín R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917. — View Citation

Francis NK, Curtis NJ, Conti JA, Foster JD, Bonjer HJ, Hanna GB; EAES committees. EAES classification of intraoperative adverse events in laparoscopic surgery. Surg Endosc. 2018 Sep;32(9):3822-3829. doi: 10.1007/s00464-018-6108-1. Epub 2018 Feb 12. — View Citation

Kaafarani HM, Mavros MN, Hwabejire J, Fagenholz P, Yeh DD, Demoya M, King DR, Alam HB, Chang Y, Hutter M, Antonelli D, Gervasini A, Velmahos GC. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg. 2014 Jun;218(6):1120-8. doi: 10.1016/j.jamcollsurg.2013.12.060. Epub 2014 Feb 28. — View Citation

Kazaryan AM, Røsok BI, Edwin B. Morbidity assessment in surgery: refinement proposal based on a concept of perioperative adverse events. ISRN Surg. 2013 May 16;2013:625093. doi: 10.1155/2013/625093. Print 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent	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	03-01-2022 to 03-15-2022
Primary	Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade	03-01-2022 to 03-15-2022
Primary	Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Cohen's Kappa	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa	03-01-2022 to 03-15-2022
Primary	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	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	03-01-2022 to 03-15-2022
Primary	Evaluate theTime to complete grading (minutes) using the 5 iAEs grading systems	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)	03-01-2022 to 03-15-2022
Primary	Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in term of Distribution of responses by count and percent	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	03-16-2022- to 06-01-2022
Primary	Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in terms of Percent agreement of grade	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade	03-16-2022- to 06-01-2022
Primary	Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Cohen's Kappa	Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa	03-16-2022- to 06-01-2022
Primary	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	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	03-16-2022- to 06-01-2022
Primary	Evaluate Time to complete grading (minutes)using the ICARUS Calculator	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)	03-16-2022- to 06-01-2022
Primary	Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	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: ICARUS calculator vs. EAUiaiC; ICARUS calculator vs. iAE severity; ICARUS calculator vs. Modified Satava; ICARUS calculator vs. ClassIntra; ICARUS calculator vs. EAES Classification	03-16-2022- to 06-01-2022
Primary	Determination of benefit in efficiency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	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: ICARUS calculator vs. EAUiaiC; ICARUS calculator vs. iAE severity; ICARUS calculator vs. Modified Satava; ICARUS calculator vs. ClassIntra; ICARUS calculator vs. EAES Classification	03-16-2022- to 06-01-2022
Primary	Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	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: ICARUS calculator vs. EAUiaiC; ICARUS calculator vs. iAE severity; ICARUS calculator vs. Modified Satava; ICARUS calculator vs. ClassIntra; ICARUS calculator vs. EAES Classification	03-16-2022- to 06-01-2022
Primary	Determination of benefit in inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events	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: ICARUS calculator vs. EAUiaiC; ICARUS calculator vs. iAE severity; ICARUS calculator vs. Modified Satava; ICARUS calculator vs. ClassIntra; ICARUS calculator vs. EAES Classification	03-16-2022- to 06-01-2022
Secondary	Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire	Assess the physician satisfaction using a validated questionnaires System Usability Scale (SUS) questionnaire	03-16-2022- to 06-01-2022
Secondary	Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire.	Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS) and Usefulness, Satisfaction and Ease of Use (USE) questionnaire	03-16-2022- to 06-01-2022
Secondary	Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS)	Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS)	03-16-2022- to 06-01-2022

External Links

•   ICARUS Calculator