Surgical flow disturbances in dedicated minimally invasive surgery suites: an observational study to assess its supposed superiority over conventional suites.

BACKGROUND: Minimally invasive surgery (MIS) is frequently compromised by surgical flow disturbances due to technology- and equipment-related failures. Compared with MIS in a conventional cart-based OR, performing MIS in a dedicated integrated operating room (OR) is supposed to be beneficial to patient safety. The aim of this study was to compare a conventional OR with an integrated OR with regard to the incidence and effect of equipment-related surgical flow disturbances during an advanced laparoscopic gynecological procedure [laparoscopic hysterectomy (LH)]. METHODS: Using video recording, 40 LHs performed between November 2010 and April 2012 (20 in a conventional cart-based OR and 20 in an integrated OR) were analyzed by two different observers. Outcome measures were the number, duration and effect (on a seven-point ordinal scale) of the surgical flow disturbances (e.g., malfunctioning, intraoperative repositioning, setup device). RESULTS: A total of 103 h and 45 min was observed. The interobserver agreement was high (kappa .85, p < .001). Procedure time was not significantly different (NS) [conventional OR vs. integrated OR, minutes ± standard deviation (SD), mean 161 ± 27 vs. 150 ± 34]. A total of 1651 surgical flow disturbances were observed (mean ± SD per procedure 40.8 ± 19.4 vs. 41.8 ± 15.9, NS). The mean number of surgical flow disturbances per procedure with regard to equipment was 6.3 ± 3.7 versus 8.5 ± 4.0, NS. No clinically relevant differences in the mean effect of these disturbances on the surgical flow between the two OR setups were observed. CONCLUSIONS: Performing LH in an integrated OR did not reduce the number of surgical flow disturbances nor the effect of these disturbances. Furthermore, in the integrated OR, repositioning of the monitors was a frequent and time-consuming source of disturbance. In order to maintain the high standard of surgical safety, the entire surgical team has to be aware that by performing surgery in an integrated OR different potential source for disruption arise.

Designing an operating theatre for awake procedures: A solution to improve multimodality information input.

OBJECTIVE: Many neurosurgical procedures are now performed with the patient aware in order to allow interactions between the patient and healthcare professionals. These procedures include awake brain surgery and spinal cord stimulation (SCS), lead placement for treatment of refractory chronic back and leg pain. Neurosurgical procedures under local anaesthesia require optimal intraoperative cooperation of the patient and all personnel involved in surgery. In addition to accommodating this extra source of intraoperative information all other necessary sources of data relevant to the procedure must be presented. The concept of an operating room dedicated to neurosurgical procedures performed aware and accommodating these concepts is presented, and some evidence for improvements in outcome presented, deriving from a series of patients implanted with spinal cord stimulators before and after the operating theatre was brought into service. RESULTS AND DISCUSSION: In addition to the description, two videos demonstrate the facility online. Beyond this qualitative evidence, quantitative improvement in patient outcome is evidenced by the series presented: 91.3% of patients operated in the awake anaesthesia-dedicated theatre obtained adequate low back pain coverage, versus 60.0% for patients operated before (p = 0.028). CONCLUSION: The concept of such an operating room is a step in improving the outcome by improving the presentation of all types of information to the operating room staff most notably in the example of aware procedures.

Electromagnetic Navigation Bronchoscopy Integrated Non-intubated Uniportal VATS in Localization and Resection of Pulmonary Nodules.

Background: With the development of computed tomography, the detection rate of pulmonary nodules is increasing. Accurate localization, minimally invasive resection, and rapid recovery are the most concentrated issues in modern thoracic surgery. However, some traditional procedures, including CT-guided localization and general intubated anesthesia, might prolong the operation and postoperative recovery. The integrated operating room provides a practical approach to achieve precise pulmonary nodule localization with real-time images using electromagnetic navigation bronchoscopy (ENB). Meanwhile, the minimally invasive video-assisted thoracoscopic surgery (VATS) under non-intubated anesthesia is also applied in the same place, enhancing operative efficiency and recovery after surgery. Method: The patients with pulmonary nodules resection who underwent nodules localization and uniportal VATS under non-intubated anesthesia in the integrated operating room between September 2018 and December 2021 were identified and collected. They all received ENB localization before uniportal VATS under non-intubated anesthesia, provided by the same group of anesthesiologists and surgeons. Perioperative data of patients were analyzed and evaluated to demonstrate the feasibility and efficiency of the procedure. Result: A total of 243 patients with 251 pulmonary nodules underwent ICG staining localization by ENB. The mean calibration time and navigation time were 0.91 ± 0.43 min and 10.56 ± 7.24 min, respectively. Overall, successful navigation occurred in 248 (98.80%) nodules. All patients received thoracoscopic surgery after localization, including wedge resection (231, 92.03%), segmentectomy (13, 5.18%), and lobectomy (7, 2.79%). All nodules were completely resected without serious complications. The mean postoperative hospital was 1.80 ± 0.83 days. Conclusion: ENB localization and nodules resection under non-intubated uniportal VATS in the integrated operating room provides a feasible and efficient approach to the pulmonary nodules patients, favoring the treatment precision and enhanced recovery.

Implementation of integrated operating rooms: how much time is saved and how do medical staff experience the upgrading? A mixed methods study in Denmark.

OBJECTIVES: To evaluate staff experiences of the implementation and use of integrated operating rooms (IORs) in comparison to conventional operating rooms (CORs) in Denmark. DESIGN: This study used a mixed methods approach by combining quantitative (registry-based analysis of surgical time) and qualitative (interviews with experienced surgical staff) perspectives. SETTING: Hospitals in Denmark. METHODS: The quantitative component compared the time consumption of patients between the integrated and CORs in two hospital departments at Aarhus University Hospital. Data were extracted from the administrative system in the hospital. Independent t-tests were used to estimate the statistical differences in the mean time spent on patients between the two operating rooms (ORs), and linear regression was applied to adjust for the potential influence of the surgeon. The explorative qualitative research component involved interviews with 20 informants from 10 hospital departments across seven Danish hospitals, all of whom participated between February and April 2019. Data were analysed using thematic analysis. RESULTS: The quantitative analyses showed that preparation time for lobectomy was significantly lower and completion time for cholecystectomy significantly higher in the integrated compared with CORs. No other statistically significant differences were found. The qualitative analysis showed that some nurses experienced better cooperation with the surgeon and that non-sterile nurses experienced an improved working environment in the integrated compared with CORs. Surgical staff experienced that the IORs led to improved workflow during surgery. CONCLUSIONS: This study identified no disadvantages regarding the use of IORs compared with CORs. The quantitative component of the research did not identify convincing statistically significant differences in the time consumption per patient between the ORs and according to the qualitative analyses IORs were not experienced by study participants to lead to major improvements among staff.

Numerical and experimental investigation of air distribution in a full-scale experimental barn-integrated operating room for general thoracic surgery.

BACKGROUND: Barn-integrated operating rooms have been used in an effort to save space and improve operating room efficiency during orthopedic surgeries. This study aimed to investigate the feasibility of performing several thoracic surgeries in a barn-integrated operating room simultaneously. METHODS: Both numerical simulation and field measurement approaches were applied to evaluate the performance of the ventilation system for the barn-integrated operating room. Computational fluid dynamics (CFD) method was applied to simulate airflow velocity field and particle concentration field. On-site test of airflow velocities were measured with a thermal anemometer. Bacteria-carrying particle (BCP) deposition and distribution was estimated using passive air sampling (PAS) and active air sampling (AAS) methods during mock surgeries. RESULTS: The airflow distribution and concentration contours showed the barn-integrated operating room to be highly effective in controlling the concentration of airborne bacteria in the operating fields. The airflow and bacteria count met the current standard of GB50333-2013 Specifications, and there was no evidence of air mixing between cabins. CONCLUSIONS: A barn-integrated operating room with several ultraclean operating tables in a single room would be a viable proposition for general thoracic surgeries in the future. As well as achieving a satisfactory level of contamination control, such an approach would reduce operating costs.

[Robotics and augmented reality : Current state of development and future perspectives]. / Robotik und "augmented reality" : Aktueller Entwicklungsstand und Zukunftsperspektive.

BACKGROUND: Digitalization in surgery is gaining attention in the surgical community, with robotics and augmented reality as key issues. ROBOTICS: The term surgical robot is basically not adequate to describe currently available telesupport and manipulation systems. These are passive tools which have to be activated by the surgeon and only provide relatively low levels of active support. Accordingly, justification of use is currently difficult with respect to the cost-benefit relationship. A real breakthrough will be achieved by upgrading them into genuine intelligent and collaborative support systems and justify the term as the true meaning of robotics. AUGMENTED REALITY (AR): Augmented or enriched reality improves or facilitates normal sensory perception by the integration of additional information of a different nature. Intuitive perception of the surgical site would have the potential to revolutionize surgery, but prior to clinical use, the matching of the real and the virtual world still has to be optimized (referencing); however, AR is now already a valuable tool for training and simulation as well as workflow support in the operating room (OR). CRITICAL COMMENT AND PERSPECTIVES: The promising new technological development towards the future cooperative surgical OR environment, including both robotic and AR modules, will have a significant impact on surgery, even in the mid-term. Decisive for this is that surgeons actively take part in the evaluation of this process to ensure that future "intelligent" tools will remain mere assistant or supporting systems.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices.

The new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

OR.NET RT: how service-oriented medical device architecture meets real-time communication.

Today's landscape of medical devices is dominated by stand-alone systems and proprietary interfaces lacking cross-vendor interoperability. This complicates or even impedes the innovation of novel, intelligent assistance systems relying on the collaboration of medical devices. Emerging approaches use the service-oriented architecture (SOA) paradigm based on Internet protocol (IP) to enable communication between medical devices. While this works well for scenarios with no or only soft timing constraints, the underlying best-effort communication scheme is insufficient for time critical data. Real-time (RT) networks are able to reliably guarantee fixed latency boundaries, for example, by using time division multiple access (TDMA) communication patterns. However, deterministic RT networks come with their own limitations such as tedious, inflexible configuration and a more restricted bandwidth allocation. In this contribution we overcome the drawbacks of both approaches by describing and implementing mechanisms that allow the two networks to interact. We introduce the first implementation of a medical device network that offers hard RT guarantees for control and sensor data and integrates into SOA networks. Based on two application examples we show how the flexibility of SOA networks and the reliability of RT networks can be combined to achieve an open network infrastructure for medical devices in the operating room (OR).

From SOMDA to application - integration strategies in the OR.NET demonstration sites.

The effective development and dissemination of the open integration for the next generation of operating rooms require a comprehensive testing environment. In this paper, we present the various challenges to be addressed in demonstration applications, and we discuss the implementation approach, the foci of the demonstration sites and the evaluation efforts. Overall, the demonstrator setups have proven the feasibility of the service-oriented medical device architecture (SOMDA) and real-time approaches with a large variety of example applications. The applications demonstrate the potentials of open device interoperability. The demonstrator implementations were technically evaluated as well as discussed with many clinicians from various disciplines. However, the evaluation is still an ongoing research at the demonstration sites. Technical evaluation focused on the properties of a network of medical devices, latencies in data transmission and stability. A careful evaluation of the SOMDA design decisions and implementations are essential to a safe and reliable interoperability of integrated medical devices and information technology (IT) system in the especially critical working environment. The clinical evaluation addressed the demands of future users and stakeholders, especially surgeons, anesthesiologists, scrub nurses and hospital operators. The opinions were carefully collected to gain further insights into the potential benefits of the technology and pitfalls in future work.

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

OR.NET: multi-perspective qualitative evaluation of an integrated operating room based on IEEE 11073 SDC.

PURPOSE: Clinical working environments have become very complex imposing many different tasks in diagnosis, medical treatment, and care procedures. During the German flagship project OR.NET, more than 50 partners developed technologies for an open integration of medical devices and IT systems in the operating room. The aim of the present work was to evaluate a large set of the proposed concepts from the perspectives of various stakeholders. METHOD: The demonstration OR is focused on interventions from the head and neck surgery and was developed in close cooperation with surgeons and numerous colleagues of the project partners. The demonstration OR was qualitatively evaluated including technical as well as clinical aspects. In the evaluation, a questionnaire was used to obtain feedback from hospital operators. The clinical implications were covered by structured interviews with surgeons, anesthesiologists and OR staff. RESULTS: In the present work, we qualitatively evaluate a subset of the proposed concepts from the perspectives of various stakeholders. The feedback of the clinicians indicates that there is a need for a flexible data and control integration. The hospital operators stress the need for tools to simplify risk management in openly integrated operating rooms. CONCLUSION: The implementation of openly integrated operating rooms will positively affect the surgeons, the anesthesiologists, the surgical nursing staff, as well as the technical personnel and the hospital operators. The evaluation demonstrated the need for OR integration technologies and identified the missing tools to support risk management and approval as the main barriers for future installments.