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

NCT05270603 | Unknown

• 1 other identifier: UP-21-01010
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ICARUS; Intraoperative Complications; ICARUS Calculator

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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: 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

  03-16-2022- to 06-01-2022

• 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: 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

  03-16-2022- to 06-01-2022

• 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: 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

  03-16-2022- to 06-01-2022

• 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: 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

  03-16-2022- to 06-01-2022

Secondary Outcomes (3)

• Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire

  03-16-2022- to 06-01-2022

• 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

• Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS)

  03-16-2022- to 06-01-2022

Study Arms (2)

ICARUS Calculator Raters (Intervention Group)

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

Other: ICARUS intraoperative adverse events calculator

Cognitive Grading Raters (Control Group)

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

Other: ICARUS intraoperative adverse events calculator

Interventions

ICARUS intraoperative adverse events calculator OTHER

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.

Cognitive Grading Raters (Control Group); ICARUS Calculator Raters (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study team will identify corresponding authors who have published articles at any point during 2019-2021 in key American and European scientific surgical journals. The study team plans to email up to 1500 authors from each of these journals - though, many of these journals will not likely have substantially fewer corresponding authors. Specifically, these journals will be associated with one or more of the following specialties: Anesthesiology Interventional Radiology Interventional Cardiology Cardiothoracic Surgery Colon and rectal surgery General Surgery Gynecologic oncology Gynecology and obstetrics Neurological Surgery Ophthalmologic Surgery Oral and maxillofacial Surgery Orthopaedic Surgery Otorhinolaryngology Plastic Surgery Urology Vascular Surgery

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90005, United States

Location

Related Publications (6)

• Biyani CS, Pecanka J, Roupret 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.

  PMID: 31787430 BACKGROUND

• 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.

  PMID: 24702887 BACKGROUND

• Kazaryan AM, Rosok 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.

  PMID: 23762627 BACKGROUND

• 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, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin 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.

  PMID: 32843333 BACKGROUND

• 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.

  PMID: 29435754 BACKGROUND

• 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.

  PMID: 34430764 BACKGROUND

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Cacciamani, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Research Urology

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 8, 2022
• Study Start: March 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: June 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

US (1)