6640-- ManoScan® ESO High Resolution Manometry System
Statement of Work Study Title: Defining novel pharyngeal pressure metrics to predict dysphagia treatment outcomes and clinical prognosis using high-resolution manometry Equipment Title: High Resolutio... Statement of Work Study Title: Defining novel pharyngeal pressure metrics to predict dysphagia treatment outcomes and clinical prognosis using high-resolution manometry Equipment Title: High Resolution Manometry (pHRM) ManoScan® system (ManoScan® ESO High Resolution Manometry System) Background Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. In 2016, speech-language pathologists working in the VA completed more than 102,905 evaluation and 77,786 treatment procedures for oropharyngeal dysphagia. This highlights not only the incidence of suspected dysphagia in the Veteran population but also the substantial need for dysphagia management with appropriate outcomes tracking. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function. We propose that adding pHRM to standard assessments will help address three current issues: 1) lack of objective measures to accurately monitor treatment effects; 2) uncertainty of how physiological measures relate to patient-reported outcome measures; and 3) absence of prognostic algorithms that predict treatment effects. This proposed project will address our central hypotheses that objective swallowing measures (including pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. This work begins to address a significant deficit in knowledge and thus clinical care: How does swallowing function change following treatment? Dysphagia is a significant healthcare burden for Veterans; the clinical framework used to justify treatment is weakly supported by research; and dysphagia sequelae represent a major component of U.S. health care spending annually (a half billion dollars). With advances in clinical tools to measure swallowing, we can evaluate function with greater precision. This work leverages several novel recent innovations in instrumentation and mathematical modelling/computer programming to create a more robust clinical environment that will empower clinicians, patients, caregivers, and healthcare networks to provide guided and justified care of dysphagia. Combining objective pHRM data with other measures of swallowing physiology and patient-centered factors will support the creation of algorithms to track and predict rehabilitative success. When these aims are completed, we will set the path for a precision medicine approach that can be used to investigate the role of any new, novel, or even poorly supported dysphagia treatment that has clinical promise but needs an evidence-base. The support and success of this research vision will lead to a paradigm shift in the care of Veterans with dysphagia. Oropharyngeal dysphagia is a devastating condition that affects 1 in 25 adults, leading to debilitating psychosocial sequelae and life-threatening complications, such as aspiration pneumonia, as well as 500 million dollars of annual healthcare spending. In 2016, speech-language pathologists working in the VA completed more than 102,905 evaluation and 77,786 treatment procedures for oropharyngeal dysphagia. This highlights not only the incidence of suspected dysphagia in the Veteran population but also the substantial need for dysphagia management with appropriate outcomes tracking. Clinical tools available for monitoring dysphagia therapy outcomes are limited, preventing the development of prognostic clinical algorithms, limiting accuracy in interventions, and undermining confidence in patient care. Pharyngeal high-resolution manometry (pHRM) provides direct and objective measurement of swallow-related pressure and timing events in the pharynx. Research by our team has resulted in a normative pHRM database and ensured that pHRM quantifies the complex physiology of normal and intentionally perturbed human swallowing with detail, consistency, and reliability. A critical step forward in dysphagia management is evidencing the clinical utility of pHRM This study is designed to advance dysphagia management by capturing objective data following treatment, with the long-term goal of improving precision and predictive capabilities of dysphagia diagnostic tools. We propose that adding pHRM to standard assessments, biological data, and patient reported outcome measures will address three issues: 1) lack of objective measures to adequately monitor treatment effects; 2) uncertainty of how physiological measures relate to patient-reported outcome measures; and 3) absence of prognostic algorithms that predict treatment effects. This application is innovative and will influence the management of millions of patients, potentially reduce dysphagia-related mortality, provide realistic treatment expectations, and improve utilization of resources. This multi-site trial will follow a cohort of Veterans with dysphagia (n=150) for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. During treatment, patients will undergo pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome (PRO) questionnaires at 3 standardized time points: baseline, 4 weeks after treatment initiation, and after treatment completion (8 weeks). Non-dysphagic controls (n=50) will also undergo data collection at parallel time points. We propose to achieve our objectives by using the data collected to complete the following three specific aims: To quantify change in pHRM and other measures of swallowing function resulting from dysphagia treatment. This aim will a) identify pHRM metrics that characterize the diagnoses of pharyngeal dysphagia due to muscle weakness at baseline; b) document physiological progress, or lack thereof, over the course of dysphagia therapy, and c) determine the normal variability of pHRM and other metrics in non-dysphagic adults over time. Logistic regression will discern which pressure metrics, calculated from baseline pHRM data, best define the patient group compared to normative values. All metrics will be compared across time points to identify which metrics change with therapy, and how they change relative to non-dysphagic controls. Hypotheses: Clusters of metrics will distinguish the patients from controls at baseline. Metrics will remain stable in controls over time. Clusters of metrics will change in patients with successful treatment in a direction towards normative values. Significance: Identification of clinically-relevant pressure metrics, as well as documentation of natural pressure variability, will improve the validity of pHRM as a clinically useful tool. To determine which combination of standard of care and/or pHRM-based metrics best track with outcome measures of treatment effect. Magnitude of change between time points will be calculated for each metric extracted from videofluoroscopy, diet, and pHRM data and analyzed using regression models, with treatment effect (change in total Sydney Swallow Questionnaire (SSQ) score and Modified Barium Swallow Impairment Profile(MBSImPTM ) pharyngeal impairment score between time points) as the dependent variable. Hypothesis: pHRM metrics will account for significant variance in regression models predicting treatment effect. Significance: Identifying a combination of metrics that change in response to treatment will provide clinicians with salient variables to monitor and will provide data for prognostic algorithms. To develop multimodal prognostic algorithms that predict treatment success from baseline diagnostic measures. We will use mathematical models (artificial neural network programming and regression models) populated with physiological and patient-specific data to identify metrics most predictive of treatment success (change toward control values on SSQ and MBSImPTM). Hypothesis: pHRM data and factors such as age and adherence will nest with treatment success. Significance: Currently, no prognostic algorithms exist for dysphagia rehabilitation. This aim will provide a tool to help guide patients and clinicians towards realistic expectations for treatment outcomes. Swallowing Disorders Impact Personal Health, Quality of Life, and Healthcare Cost to Society: Swallowing is a fundamental, yet biomechanically complex, function of the human body. Standard of care diagnostic and outcome tools used in the evaluation of the oropharyngeal swallowing are largely qualitative in nature and do not allow for the quantification of the pressure abnormalities that occur with swallowing dysfunction (dysphagia). As such, the proposed research is highly significant in its applying a novel and objective tool, pharyngeal high-Âresolution manometry (pHRM), as an adjunct for diagnosis, prognosis, and outcome tracking in personalized clinical care of oropharyngeal dysphagia. Once diagnosed with dysphagia, the ability to restore swallowing function to an optimal state significantly impacts overall health status. Dysphagia is a tremendous financial burden, has disabling psychosocial consequences, and increases risk of hospitalization and life-threatening medical complications including malnutrition, dehydration, and aspiration pneumonia. Therefore, improvement in precision of dysphagia rehabilitation is imperative. Oropharyngeal Dysphagia Treatment Outcome Measurement: Current State & Limitations: Clinical rehabilitation of swallowing function can be directed at one or more physiological goals: 1) improvement in strength of swallowing-Ârelated muscle activity; 2) relief of upper esophageal sphincter dysfunction; and/or 3) improvement in the timing and coordination of swallowing events. To address these physiological processes, various therapeutic options are used alone or in combination. While most theories supporting these treatments are physiologically sound, there remains a major gap in the literature confirming the physiological changes following these treatments. Although videofluoroscopy remains custom for dysphagia diagnosis and monitoring of treatment progress, this standard tool alone is ineffective in providing unbiased interpretation, direct and reproducible measurements, or complete understanding of mechanism of the dysphagia nor the functional changes following dysphagia treatment. It is also unclear how patient-Âreported outcome measures for dysphagia, and biological conditions such as age and disease severity, are related to physiological changes in swallowing function. Our research will fill this critical gap in knowledge and will pave the way for a personalized medicine approach for dysphagia. Pharyngeal HRM is Poised to Support Dysphagia Treatment Outcome Measurement: Measurement of intraluminal pressure provides quantification of pharyngeal muscle functionality. Pharyngeal high-resolution manometry (pHRM) is a minimally-invasive, non-radiation based tool used to quantify pressure generation and gradients within the alimentary canal at high spatiotemporal resolution (50Hz, sensors every cm, spanning 36cm). Published reports from around the world have illustrated the successful use of pHRM to define normal pressure events and the effects of maneuvers, bolus volumes, and age. pHRM incorporated with impedance allows for bolus tracking, pharyngeal residue identification, and airway invasion risk prediction. Thus far, pHRM has been applied to study pressure characteristics in a variety of swallowing dysfunction pathologies. Preliminary evidence has been published illustrating case examples using pHRM to document progress from pharyngeal muscular strengthening and outlet obstruction relief. However, the heterogeneous nature of dysphagia warrants study of a large number of patients using multivariate analyses and available relevant data. Scientific Premise, Central Hypotheses, and Clinical Impact of Proposed Study: The premise of this work lies in the overwhelming evidence of the successful, reproducible, and informative application of pHRM, alongside other standard measures, in the evaluation of healthy swallowing physiology and detection of swallowing dysfunction. Preliminary evidence illustrates that pHRM metrics can improve characterization of the neuromuscular failures underlying any form of dysphagia and can document change with treatment over time (specifically in pharyngeal strengthening and UES dysfunction therapy cases). The strength of these data indicates that pHRM has moved from a state of infancy to a point where it now has the potential to be useful in dysphagia clinical care. However, further study is needed to provide confirmation of its clinical usefulness and discern all the salient metrics in this heterogeneous group of patients. Further, there are currently no prognostic algorithms for swallowing rehabilitation. Small peer-reviewed studies have shown the potential power in pHRM to train neural network systems to classify pathological states of swallowing. We hypothesize that introducing pHRM will add precision to clinical outcome care, allow us to define relationships among physiological changes and patient reported outcomes, and provide prognostic algorithms that predict treatment effects. Studying patient populations with pHRM will also add greatly to the understanding of the mechanisms responsible for unique patient-specific manifestations of dysphagia. By determining objective measures that quantify therapeutic clinical improvement, or lack thereof, this work will result in additional clinical tools that can be used to target treatment plans for patients based on individualized pressureÂrelated metrics and/or prognostic algorithms. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans. Scope The High Resolution Manometry (pHRM) ManoScan® system (ManoScan® ESO High Resolution Manometry System will be used to address three issues: 1) lack of objective measures to adequately monitor treatment effects; 2) uncertainty of how physiological measures relate to patient-reported outcome measures; and 3) absence of prognostic algorithms that predict treatment effects. This application is innovative and will influence the management of millions of patients, potentially reduce dysphagia-related mortality, provide realistic treatment expectations, and improve utilization of resources. Tasks or Requirements: ManoScan ESO Z module and catheter provide circumferential assessment of bolus movement as well as physiological mapping of esophageal motor function. Impedance measurements to improve the ability to predict the success of failure of bolus movements through the esophagus Maps from the pharynx to the stomach, with a single placement of the catheter High resolution esophageal catheter with impedance: 36 channels with 12 measuring points per sensor provide 432 points of measurement 18 impedance channels display bolus transition from pharynx to esophagus 4.2 mm diameter True circumferential sensors Selection Criteria The ManoScan ESO high resolution manometry system enables full evaluation of the motor functions of the esophagus. The system allows for enhanced sensitivity that provides useful information to support diagnosis of conditions like dysphagia, achalasia, and hiatal hernia. By precisely quantifying the contraction of the esophagus and its sphincters, a more complete pressure profile for patients is provided. Attributes unique to the ManoScan System include: Portable cart system LCD flat panel touchscreen with articulating arm Modular data acquisition controller Windows®*-based operating system LAN connection and WiFi-enabled Integrated catheter auto-calibration system Large lockable wheels Patient isolation transformer High-speed quality printer ManoView software Procedural tools yield precise measurement and detailed data analysis Anatomical profile display includes graphical pointers to identify landmarks, including LES, UES, and PIP eSleeve function instantly measures and ensures that sphincter barrier pressures are correctly recorded, despite movement of the LES/EGJ during swallowing High-resolution and conventional displays provide versatile and complete motility visualization ManoView software can be installed on any Windows®*-based computer
Data sourced from SAM.gov.
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