Abstract

Introduction: Patient and team safety are paramount in healthcare, but medical errors remain the third leading cause of death. In laparoscopy, a surgical black box, based on aviation industry principles, provides valuable information about events occurring during these procedures.1 The system collects and synchronizes audio-visual and patient-related data for semi-automatic evaluation of technical- and non-technical skills (NTS) and environmental factors. In endovascular surgery, this technology may also provide useful knowledge about type, cause and frequency of perioperative events. Yet, high reliance on multidisciplinary teams and high equipment demands including radiation and a mobile C-arm pose additional challenges to transfer the black box technology in this field. We present our experience to adapt a black box system for evaluation of endovascular surgical procedures. Methods: Prior to installation, approval was obtained from all relevant hospital parties. Together with the original black box team and partners from biomedical, infrastructural and IT departments, an implementation plan was created for adapting the black box to our hybrid angiosuite, equipped with a Philips Allura Xper FD20 system. Video-evaluation frameworks were chosen with the black box research team. Technical skill evaluation tools were chosen after a non-structured analysis of the literature. NTS and environmental factor evaluation frameworks were already available in the system. A framework for radiation safety evaluation has been self-developed and is currently being validated. Results: Ethics approval took 54 days and approval of juridical and financial agreement took 252 days. All team members (surgeons, nurses, anaesthesiologists) were informed during informative sessions and informed consent was collected. Site assessment and hardware installation both required two days. Four ceiling-mounted cameras were used to capture team movement and activity in the angiosuite, which were sometimes blocked by the C-arm. Three multidirectional ceiling microphones were installed to capture team conversations and environmental noise. A direct connection with the C-arm system captures the fluoroscopy image and radiation safety parameters. Patient hemodynamic monitoring is captured through the anaesthesia monitor and provides information about event severity and physiologic consequences. Surgical technical performance is assessed with the 'Global Rating Scale of Endovascular Performance' and the 'Examiner's Checklist' frameworks. The NOTSS, SPLINTS and ANTS frameworks were picked to assess non-technical skills of surgical, nursing and anaesthesiology teams, respectively. The 'Disruption in Surgery Index' framework assesses disruptive and environmental factors. A pilot study of 20 elective endovascular treatments of symptomatic iliac and femoropopliteal atherosclerotic disease to assess feasibility and reliability of black box-driven analysis is in progress. Data will be available at the annual meeting. Conclusion: To our knowledge, this innovative black box technology is the first to be installed in a hybrid angiosuite worldwide. Ultimately, this may help identify the number of errors or near-misses occurring in a hybrid angiosuite. This may allow each centre to identify safety risks and map operational sequences leading to adverse events in endovascular surgery, ultimately leading to educational interventions based on real situations so that every error or near-miss remains unique. Disclosure: Nothing to disclose

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