Coagulation Management of Critically Bleeding Patients With Viscoelastic Testing Presented as a 3D-Animated Blood Clot (The Visual Clot): Randomized Controlled High-Fidelity Simulation Study.
Clara Castellucci, Amos Malorgio, Alexandra Dinah Budowski, Samira Akbas, Michaela Kolbe, Bastian Grande, Julia Braun, Christoph B Noethiger, Donat R Spahn, David Werner Tscholl, Tadzio Raoul Roche
Author Information
Clara Castellucci: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Amos Malorgio: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Alexandra Dinah Budowski: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Samira Akbas: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Michaela Kolbe: Simulation Centre, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Bastian Grande: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Julia Braun: Department of Epidemiology, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland. ORCID
Christoph B Noethiger: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Donat R Spahn: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
David Werner Tscholl: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
Tadzio Raoul Roche: Institute of Anaesthesiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. ORCID
BACKGROUND: Guidelines recommend using viscoelastic coagulation tests to guide coagulation management, but interpreting the results remains challenging. Visual Clot, a 3D animated blood clot, facilitates interpretation through a user-centered and situation awareness-oriented design. OBJECTIVE: This study aims to compare the effects of Visual Clot versus conventional viscoelastic test results (rotational thrombelastometry [ROTEM] temograms) on the coagulation management performance of anesthesia teams in critical bleeding situations. METHODS: We conducted a prospective, randomized, high-fidelity simulation study in which anesthesia teams (consisting of a senior anesthesiologist, a resident anesthesiologist, and an anesthesia nurse) managed perioperative bleeding scenarios. Teams had either Visual Clot or ROTEM temograms available to perform targeted coagulation management. We analyzed the 15-minute simulations with post hoc video analysis. The primary outcome was correct targeted coagulation therapy. Secondary outcomes were time to targeted coagulation therapy, confidence, and workload. In addition, we have conducted a qualitative survey on user acceptance of Visual Clot. We used Poisson regression, Cox regression, and mixed logistic regression models, adjusted for various potential confounders, to analyze the data. RESULTS: We analyzed 59 simulations. Teams using Visual Clot were more likely to deliver the overall targeted coagulation therapy correctly (rate ratio 1.56, 95% CI 1.00-2.47; P=.05) and administer the first targeted coagulation product faster (hazard ratio 2.58, 95% CI 1.37-4.85; P=.003). In addition, participants showed higher decision confidence with Visual Clot (odds ratio 3.60, 95% CI 1.49-8.71; P=.005). We found no difference in workload (coefficient -0.03, 95% CI -3.08 to 2.88; P=.99). CONCLUSIONS: Using Visual Clot led to a more accurate and faster-targeted coagulation therapy than using ROTEM temograms. We suggest that relevant viscoelastic test manufacturers consider augmenting their complex result presentation with intuitive, easy-to-understand visualization to ease users' burden from unnecessary cognitive load and enhance patient care.
