Evaluation of a Navigation System for ENT with Surgical Efficiency Criteria

Abstract

The aim of this study is the evaluation of a navigation system (NaviBase) for ENT surgery. For this purpose, a new methodology for the evaluation of surgical and ergonomic system properties has been developed. The practicability of the evaluation instruments will be examined using the example of the overall assessment of the system in comparison with the current surgical standard and with other systems using clinical efficiency criteria. The evaluation is based on 102 ENT surgical applications; of these, 89 were functional endoscopic sinus surgeries (FESS). The evaluation of surgical and ergonomic performance factors was performed by seven ENT surgeons. To evaluate surgical system properties, the Level of Quality (LOQ) in 89 cases of the FESS was determined. It compares the existing information of the surgeon with that of the navigation system on a scale of 0 to 100 and with a mean value of 50 and places it in a relationship to the clinical impact. The intraoperative change of the planned surgical strategy (Change of Surgical Strategy) was documented. The ergonomic factors of the system with the categories of Overall Confidence (Trust), awareness of the situation (Situation Awareness), influence on the operating team, requirements for specific skills (Skill Set Requirement), and cognitive load (Workload Shift) were recorded for all surgical procedures as Level of Reliance (LOR). In the evaluation of the surgical system properties, an average evaluation of the quality of the information, as an LOQ of 63.59, resulted. Every second application of the navigation system (47.9%), on average, led to a change in the surgical strategy. An extension/enhancement of the indication of the endonasal approach through the use of the navigation system was shown in 7 of 102 (6.8%) cases. The completion of the resection in the FESS was rated by 74% of group I and 11% of group II as better in comparison with the standard approach. Total confidence shows a positive evaluation of 3.35 in the LOR. To supplement the evaluation of the navigation system, the technical parameters were included. The maximum deviation, Amax, of the displayed position of the reference value amounted to 1.93 mm. The average deviation was at 1.29 mm with an SD above all values, sd, of 0.29. The subsequent economic evaluation resulted in an effective average extra expenditure of time of 1.35 minutes per case. The overall evaluation of the system imparts application-relevant information beyond the technical details and permits comparability between different assistance systems.

Image‐guided navigation: the surgeon's perspective on performance consequences and human factors issues

“…With respect to this classification, image-guided navigation systems for minimally invasive surgery can be classified as a low to medium level of information automation, as these systems support to some degree the information acquisition and analysis of visual information from the operative site (i.e. they provide additional information needed to localize the position of the surgical instrument in relation to the patient's anatomy) while still leaving it completely up to the surgeon to draw any decisions from this information and to take any appropriate surgical action (13).…”

International Consensus Statement on Allergy and Rhinology: Rhinosinusitis

“…Other studies have not demonstrated similar benefits of IGS. [1217][1218][1219][1220] Strauss et al 1221 proposed a novel strategy for assessing the impact of IGS on surgical decision-making. In this clinical series, IGS was associated with changes in surgical technique and strategy, even for experienced surgeons.…”

Cirugía endoscópica nasosinusal y de base de cráneo asistida por navegación

“…En cuanto a sus ventajas la navegación permitiría realizar una planificación quirúrgica preoperatoria, ahorrar tiempo quirúrgico, una exploración más completa en un área potencialmente peligrosa manteniendo la indemnidad de estructuras nobles, favorecer la formación de futuros cirujanos y acortar su curva de aprendizaje, además de ser beneficiosa en la confirmación de la indemnidad quirúrgica de estructuras nobles en cirugía sinusal, especialmente en cirujanos menos experimentados 10 . Se espera que el error objetivo razonable esté en el rango de 1,5 a 2,0 mm con esta herramienta, utilizándose navegación con realidad aumentada se ha estimado un error de 1,5 mm o menos 11 , en un estudio reciente el uso de navegación virtual 3D no demostró superioridad en comparación a una guía de imagen triplana convencional 12 .…”