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ICARUS Calculator Raters (Intervention Group) for Complications (ICARUS-C Trial)

N/A
Waitlist Available
Led By Giovanni Cacciamani, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 03-01-2022 to 03-15-2022
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Surgical Procedure
  • Complications
  • Intraoperative Complications
  • Surgery Complications
  • Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~03-01-2022 to 03-15-2022
This trial's timeline: 3 weeks for screening, Varies for treatment, and 03-01-2022 to 03-15-2022 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
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
+11 more
Secondary study objectives
Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire
Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS)
Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: ICARUS Calculator Raters (Intervention Group)Experimental Treatment1 Intervention
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
Group II: Cognitive Grading Raters (Control Group)Experimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,602,645 Total Patients Enrolled
Giovanni Cacciamani, MDPrincipal InvestigatorUniversity of Southern California
2 Previous Clinical Trials
350 Total Patients Enrolled
~558 spots leftby Nov 2025