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A Non-Invasive Real-Time Localization System for Enhanced Efficacy In Annals of Biomedical Engineering (Ó 2015) DOI: 10.1007/s10439-015-1361-0 A Non-invasive Real-time Localization System for Enhanced Efficacy in Nasogastric Intubation 1 1 1 1 1 2 ZHENGLONG SUN, SHAOHUI FOONG , LUC MARE´CHAL, U-XUAN TAN, TEE HUI TEO, and ASIM SHABBIR 1Engineering Product Development Pillar, Singapore University of Technology and Design, 8 Somapah Road, Singapore 487372, Singapore; and 2Division of General Surgery (Upper Gastrointestinal Surgery), University Surgical Cluster, National University Health System, 5 Lower Kent Ridge Road, Singapore 119074, Singapore (Received 25 November 2014; accepted 9 June 2015) Associate Editor John H. Linehan oversaw the review of this article. Abstract—Nasogastric (NG) intubation is one of the most applications, which involves the insertion of a plastic commonly performed clinical procedures. Real-time tube through the nose, past the throat and down into localization and tracking of the NG tube passage at the larynx the stomach. Conventionally, insertion of the NG tube region into the esophagus is crucial for safety, but is lacking in current practice. In this paper, we present the design, analysis is manually performed ‘‘blind’’ without any visual aids and evaluation of a non-invasive real-time localization system or indications. It is a complex procedure and requires using passive magnetic tracking techniques to improve efficacy experience and expertise to avoid erroneous insertions9 of the clinical NG intubation process. By embedding a small as they are potentially associated with significant permanent magnet at the insertion tip of the NG tube, a morbidity and mortality.16,20 For example, if the tube wearable system containing embedded sensors around the neck can determine the absolute position of the NG tube inside the is misplaced through the larynx into the trachea and body in real-time to assist in insertion. In order to validate the down into the bronchi, without detection prior to feasibility of the proposed system in detecting erroneous tube feeding, patients can suffer from complications such as placement, typical reference intubation trajectories are first pneumonia which can be fatal.1,8 Therefore, prompt analyzed using anatomically correct models and localization assessment of the NG tube position to ensure correct accuracy of the system are evaluated using a precise robotic platform. It is found that the root-mean-squared tracking placement of the tube is a critical care component for accuracy is within 5.3 mm for both the esophagus and trachea clinicians to ensure patient safety as well as comfort. intubation pathways. Experiments were also designed and Currently, multiple bedside methods are available to performed to demonstrate that the system is capable of tracking assess the status of NG intubation. One of the most the NG tube accurately in biological environments even in routinely used method is the pH test which involves presence of stationary ferromagnetic objects (such as clinical instruments). With minimal physical modification to the NG aspirating fluid from the tube with a syringe after tube and clinical process, this system allows accurate and sufficient measure of the tube has been inserted to efficient localization and confirmation of correct NG tube reach the stomach. The tube is considered to be in the placement without supplemental radiographic methods which is correct position if the pH of the sampled fluid is 5.5 or considered the current clinical standard. below. However, the only definite and most accurate method for verifying the tube position used widely in Keywords—Nasogastric intubation, Magnetic localization, hospitals is still through radiography, where a chest Wearable device, Healthcare safety. X-ray is obtained. In fact, it is suggested from litera- ture that radiography would be necessary if the pH is higher than 4.18 However, the use of radiography can INTRODUCTION also lead to significant delays in subsequent clinical Nasogastric (NG) tube intubation is a common procedures (feeding, aspiration), unnecessary radioac- clinical procedure for diagnostic and therapeutic tive exposure to the patients and introduce excessive cost. Most importantly, all these techniques could only confirm the (correct or erroneous) final placement of Address correspondence to Shaohui Foong, Engineering Product the NG tube in the stomach and are unable to actively Development Pillar, Singapore University of Technology and 7,9 Design, Singapore 138682, Singapore. Electronic mail: foongshaoh monitor the intubation process in real time. As a [email protected] result, current methods including X-ray do not actively Ó 2015 Biomedical Engineering Society SUN et al. detect or prevent the occurrence of an abnormality; by to make the assembly modular allow the expensive the time erroneous insertion has been detected, the sensors to be removed, sterilized and reused. The damage has already been done. intubation procedure is also affected due to the pres- Thus, various methods have been explored to pro- ence of tethering wires from the embedded sensor at vide real-time localization for NG intubation in order the tip of the NG tube to a sensing unit outside of the to remove the time consuming and expensive X-ray tube, thereby making the process more cumbersome. process from the clinical routine. With recent In this paper, we present a novel non-invasive real- advancement in magnetic field-based tracking and time localization system for NG tube intubation that localization techniques in the past decade, this adopts passive magnetic tracking method, as shown in approach has become more and more appealing in Fig. 1. This novel approach features a compact passive biomedical applications.3,5,23 Besides its non-contact magnetic source attached to a moving target and nature, the major advantage of utilizing magnetic field localization is achieved from stationary sensors and is is that biological tissues including bones and skin in contrast with commercial EM Tracking systems possess permeability that is very close to air, which which uses a sensor affixed to a moving target and means the magnetic field can permeate through the measuring the EM field generated by a stationary field human body with minimal influence. Several studies generator to provide localization.6,17 By embedding a have evaluated the implementation of active electro- small permanent magnet (PM) at the insertion tip of magnetic (EM) tracking technology for NG intuba- the NG tube, a wearable device at the neck containing tion.6,10,11 This technology requires an actively embedded sensors can measure the passive magnetic controlled varying magnetic field to be applied on the field of the magnet in order to determine the tracking object which has miniature sensor coils localization of the NG tube inside the body. The sys- embedded inside; then the voltages induced in the tem is meticulously designed to focus on the larynx sensor coils are measured to calculate the position of region to distinguish whether the NG tube is passing the object. Based on this technology, commercialized through the esophagus (correct) or trachea (incorrect), products have been developed such as NDI Aurora which is one of the most common errors in NG intu- system and Cortrak EAS system. But such an bation. As there is minimal modification to the NG approach is not suitable for NG intubation as it tube, there is no change in the clinical procedure and involves integrating expensive sensing coils to be thus retraining of clinical staff is not required. The inserted together with a significantly inexpensive NG clinicians could be alerted immediately once an erro- tube. It requires a costly and bulky field generator and neous placement is detected and a visualizer could be system control unit in situ, which could be only avail- used to provide real-time spatial localization of the tip able in well-equipped hospitals and medical centers. It of NG tube. In the following, we first present the may require a significant redesign on the NG tube working principle of the passive magnetic tracking which are designed to be single-use apparatus, in order method, followed by discussions on the design Nasal Cavity Wearable localization device with embedded sensor network NG tube Permanent Magnet (PM) embedded at the tip of NG tube Epiglottis Tracheal Cartilages Trachea Esophagus Lungs Visualizer Stomach FIGURE 1. Overview of the real-time non-invasive magnetic localization system for nasogastric intubation. A Non-invasive Real-time Localization System requirement for the system. A prototype system is built where lr is the relative permeability of the medium, l0 and presented, and the accuracy of the proposed sys- is the magnetic permeability of free space (mT Æ mm/ tem is tested using a robotic system. Validation tests A), M is the constant strength of the dipole moment 2 i are also performed to show its feasibility and perfor- (A Æ mm ), and Pi is a vector from Pm pointing to Ps mance in biological environments. (1 £ i £ n), and R is the magnitude of the vector Pi, i Pi ¼ Ps À Pm: ð2Þ MATERIALS AND METHODS In the dipole model Eq. (1), the sensor positions are fixed, and the dipole moment M can be measured Passive Magnetic Field-Based Localization beforehand through calibration. Since there does not The principle of the passive magnetic tracking is to exist a direct solution for such non-linear equation, detect the changes in the magnetic flux density (MFD) such inverse problem is solved in the least-square of a magnetic source due to the relative distance and manner; a cost function C is defined to quantify the orientation between the magnetic source and sensors, differences between the modeled and the measured as one of them (source/sensor) is attached to the target magnetic field at all n sensors: object.19 In this application, we attach the magnetic Xn source to the NG tube, and measure its position rela- 2 C ¼ jjB i fmodelgÀB i fmeasuredgjj ; ð3Þ tive to the fixed sensors which are affixed outside the s s i¼1 body.
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