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Assessing the Added Value of Miniature X-Ray in the Setting of Portable Ultrasound in Spaceflight

INTRODUCTION: Point-of-care ultrasound (POCUS) has become the standard of care for imaging diagnosis and management in low-Earth Orbit (LEO) spaceflight and it has long been hypothesized that POCUS will also be the standard of care for exploration spaceflight. However, like the trajectory for which ultrasound became more portable and user-friendly, the mass, volume, and power requirements of radiography devices for both diagnostic and therapeutic applications have also been dramatically reduced. This study seeks to determine the clinical utility and added value of miniature x-ray (XR) for the diagnosis and management of each of the 119 conditions within NASA Exploration Medical Capability’s IMPACT Condition List (ICL) given that the medical system is presumed to already be carrying a handheld portable POCUS device. METHODS: For each condition, a team of reviewers performed a rapid systematic literature review seeking sensitivity and specificity data for both handheld portable ultrasound and miniature XR. When there was a paucity of data, subject matter expertise and clinical experience was added to semi-quantitatively score the added value of miniature XR, given an US was already available for both diagnosis and management. Diagnostic utility of a modality for a condition was evaluated in the setting of both the best- and worst-case scenario definitions included and defined by the ICL. Evidence tracing and quality of evidence scores were also recorded. RESULTS/DISCUSSION: Conditions for which it was determined that miniature XR added diagnostic or therapeutic value are provided in this presentation. Previously presented work by our team has demonstrated that XR provides diagnostic and management capabilities that are hypothesized to complement or surpass ultrasound for over one-third of medical conditions that may arise during exploration spaceflight (i.e., diagnosis of injuries to the axial skeleton, teeth, and lungs as well as management of orthopedic reductions, endotracheal tube placement, and drain placement confirmation). In the setting of known inclusion of a handheld portable POCUS device, there remains significant added value of portable miniature XR. Whether or not this added clinical benefit is worth the mass, volume, and power requirements of the radiography system remains yet unknown and is the focus of future work. LEARNING OBJECTIVES: 1) Understand the value of ultrasound and radiography in the diagnosis and management of medical comorbidities that may arise in exploration spaceflight; 2) Understand the medical conditions of highest concern on exploration class missions for which miniature x-ray may provide added value to portable ultrasound.

J G Steller↗

Assessing the Added Value of Miniature X-Ray in the Setting of US in Spaceflight

INTRODUCTION: Point-of-care ultrasound (POCUS) has become the standard of care for imaging diagnosis and management in lowEarth Orbit (LEO) spaceflight and it has long been hypothesized that POCUS will also be the standard of care for exploration spaceflight. However, like the trajectory for which ultrasound became more portable and user-friendly, the mass, volume, and power requirements of radiography devices for both diagnostic and therapeutic applications have also been dramatically reduced. This study seeks to determine the clinical utility and added value of miniature x-ray (XR) for the diagnosis and management of each of the 119 conditions within NASA Exploration Medical Capability’s IMPACT Condition List (ICL) given that the medical system is presumed to already be carrying a handheld portable POCUS device. METHODS: For each condition, a team of reviewers performed a rapid systematic literature review seeking sensitivity and specificity data for both handheld portable ultrasound and miniature XR. When there was a paucity of data, subject matter expertise and clinical experience was added to semi-quantitatively score the added value of miniature XR, given an US was already available for both diagnosis and management. Diagnostic utility of a modality for a condition was evaluated in the setting of both the best- and worst-case scenario definitions included and defined by the ICL. Evidence tracing and quality of evidence scores were also recorded. RESULTS/DISCUSSION: Conditions for which it was determined that miniature XR added diagnostic or therapeutic value are provided in this presentation. Previously presented work by our team has demonstrated that XR provides diagnostic and management capabilities that are hypothesized to complement or surpass ultrasound for over one-third of medical conditions that may arise during exploration spaceflight (i.e., diagnosis of injuries to the axial skeleton, teeth, and lungs as well as management of orthopedic reductions, endotracheal tube placement, and drain placement confirmation). In the setting of known inclusion of a handheld portable POCUS device, there remains significant added value of portable miniature XR. Whether or not this added clinical benefit is worth the mass, volume, and power requirements of the radiography system remains yet unknown and is the focus of future work. LEARNING OBJECTIVES: 1) Understand the value of ultrasound and radiography in the diagnosis and management of medical comorbidities that may arise in exploration spaceflight; 2) Understand the medical conditions of highest concern on exploration class missions for which miniature x-ray may provide added value to portable ultrasound.

Jon Steller↗

Magnetic Microspheres for Therapeutical Applications

Hyperthermia is a well known cancer therapy and consists of heating a tumor region to the elevated temperatures in the range of 40-45 C for an extended period of time (2-8 hours). This leads to thermal inactivation of cell regulatory and growth processes with resulting widespread necrosis, carbonization and coagulation. Moreover, heat boosts the tumor response to other treatments such as radiation, chemotherapy or immunotherapy. Of particular importance is careful control of generated heat in the treated region and keeping it localized. Higher heating, to about 56 C can lead to tissue thermo-ablation. With accurate temperature control, hyperthermia has the advantage of having minimal side effects. Several heating techniques are utilized for this purpose, such as whole body hyperthermia, radio-frequency (RF) hyperthermia, ultrasound technique, inductive microwave antenna hyperthermia, inductive needles (thermoseeds), and magnetic fluid hyperthermia (MFH).MFH offers many advantages as targeting capability by applying magnets. However, this technology still suffers significant inefficiencies due to lack of thermal control. This paper will provide a review of the topic and outline the ongoing work in this area. The main emphasis is in devising ways to overcome the technical difficulty in hyperthermia therapy of achieving a uniform therapeutic temperature over the required region of the body and holding it steady. The basic obstacle of the present heating methods are non-uniform thermal properties of the tissue. Our approach is to develop a novel class of magnetic fluids which have inherent thermoregulating properties. We have identified a few magnetic alloys which can serve as a suitable nano-particle material. The objective is to synthesize, characterize and evaluate the efficacy of TRMF for hyperthermia therapy.

Mazuruk, K.↗

Magnetic Microspheres and Tissue Model Studies for Therapeutical Applications

Hyperthermia is a well known cancer therapy and consists of heating a tumor region to the elevated temperatures in the range of 40-45 C for an extended period of time (2-8 hours). This leads to thermal inactivation of cell regulatory and growth processes with resulting widespread necrosis, carbonization and coagulation. Moreover, heat boosts the tumor response to other treatments such as radiation, chemotherapy or immunotherapy. Of particular importance is careful control of generated heat in the treated region and keeping it localized. Higher heating, to about 56 C can lead to tissue thermo-ablation. With accurate temperature control, hyperthermia has the advantage of having minimal side effects. Several heating techniques are utilized for this purpose, such as whole body hyperthermia, radio-frequency (RF) hyperthermia, ultrasound technique, inductive microwave antenna hyperthermia, inductive needles (thermoseeds), and magnetic fluid hyperthermia (MFH).MFH offers many advantages as targeting capability by applying magnets. However, this technology still suffers significant inefficiencies due to lack of thermal control. This paper will provide a review of the topic and outline the ongoing work in this area. The main emphasis is in devising ways to overcome the technical difficulty in hyperthermia breast therapy of achieving a uniform therapeutic temperature over the required region of the body and holding it steady for an extended period (2-3 hours). The basic shortcomings of the presently utilized heating methods stem from the non-uniform thermal properties of the tissue and the point heating characteristics of the techniques without any thermal control. Our approach is to develop a novel class of magnetic fluids, which have inherent thermoregulating properties. We have identified a few magnetic alloys which can serve as suitable nano to micron-size particle material. The objective is to synthesize, characterize and evaluate the efficacy of Thermo Regulating Magnetic Fluids (TRMF) for hyperthermia therapy. The development of a tissue model and testing the fluid dynamics of particle motion, settling, distribution in the tissue matrix and heat generation will be discussed.

Ramachandran, N.↗

Piezoelectric Charging and Wireless Communication

Modern medicine is undergoing a revolution in the application of new sensor capabilities for aiding in diagnosis of specific conditions and monitoring a variety of informative vital signs. In the past, many of the measurements were limited by what could be accomplished externally. A shift toward in-vivo monitoring for both diagnostic and therapeutic sensing and actuation [1] has created a need for low power electronics, high energy density batteries and methods to successfully power devices embedded in the body. For a review of the field and sensing capabilities see [2]. Recent studies suggest that charging with ultrasound is more efficient at longer transmission distance (> 10cm) than inductive charging [3]. In this manuscript, we discuss the modeling and experimentation that we have accomplished and demonstrate in ultrasonic charging of sensors having the form and fit of in-vivo sensors. The task goal has been to use piezoelectric transducers for wireless communication and powering of sensors internal to the human body with a goal to transmit power levels of 100 W a receiver with receiving area of 3x3 mm2 over a distance of 16 cm equivalent to human body interior. The results suggest that we can transmit power levels that exceed this baseline requirement.

Jackson, Shannon↗

Programmatic Considerations to Reduce the Risk of Adverse Renal Stone Events in Spaceflight

Introduction: Microgravity exposure may alter the likelihood that astronauts will experience renal stones. The potential risk includes both acute and chronic health issues, with the potential for significant impact on mission objectives. Methods: To understand the role of the NASA's Human Research Program (HRP) research agenda in both preventing and addressing renal stones in spaceflight, current astronaut epidemiologic data and a summary of programmatic considerations are reviewed. Results: Although there has never been a symptomatic renal stone event in a U.S. crewmember during spaceflight, urine chemistry has been altered - likely due to induced changes in renal physiology as a result of exposure to microgravity. This may predispose astronauts to stone formation, leading the HRP to conduct and sponsor research to: 1) understand the risk of stone formation in space; 2) prevent stones from forming; and 3) address stones that may form by providing novel diagnostic and therapeutic approaches. Discussion: The development of a renal stone during spaceflight is a significant medical concern that requires the HRP to minimize this risk by providing the ability to prevent, diagnose, monitor and treat the condition during spaceflight. A discussion of the risk as NASA understands it is followed by an overview of the multiple mitigations currently under study, including novel ultrasound techniques for stone detection and manipulation, and how they may function as part of a larger exploration medical system.

Antonsen, Erik↗

Clinical Outcome Metrics for Optimization of Robust Training

Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance (pre-IMM analysis) and overall mitigation of the mission medical impact (IMM analysis); 2) refine the procedure outcome and clinical outcome metrics themselves; 3) refine or develop innovative medical training products and solutions to maximize CMO performance; and 4) validate the methods and products of this experiment for operational use in the planning, execution, and quality assurance of the CMO training process The team has finalized training protocols and developed a software training/testing tool in collaboration with Butler Graphics (Detroit, MI). In addition to the "hands on" medical procedure modules, the software includes a differential diagnosis exercise (limited clinical decision support tool) to evaluate the diagnostic skills of participants. Human subject testing will occur over the next year.

Ebert, D.↗