US20030044351A1

US20030044351A1 - Standardized compositions which facilitate swallowing in dysphagic subjects

Info

Publication number: US20030044351A1
Application number: US10/227,911
Authority: US
Inventors: Jo Robbins
Original assignee: Individual
Current assignee: Wisconsin Alumni Research Foundation
Priority date: 1999-08-27
Filing date: 2002-08-26
Publication date: 2003-03-06
Also published as: CA2382641A1; WO2001015743A3; DE60021734T2; AU765723B2; JP2003508452A; US20010036439A1; WO2001015743A8; EP1210126A2; WO2001015743A2; MXPA02002071A; DE60021734D1; ATE300960T1; CA2382641C; EP1210126B1; US6461589B2; NZ517615A; AU6785500A; ES2246881T3

Abstract

Disclosed are kits containing two or more viscosity-standardized, edible solutions for evaluating human subjects for dysphagia. Also disclosed are corresponding methods of using the kits for diagnosing dysphagia and for radiographic imaging of the oropharynx.

Description

This is a continuation-in-part of co-pending application Ser. No. 09/442,704, filed Nov. 18, 1999, which claims priority to provisional application Serial No. 60/151,213, filed Aug. 27, 1999, the contents of both of which are incorporated herein by reference.[0001]

FIELD OF THE INVENTION

The invention is directed to standardized, viscosity-modified, edible formulations for use with dysphagic patients and methods to gauge the viscosity of modified foods using the standardized formulations. The formulations described herein can also be combined with a radio-opaque agent to facilitate improved dynamic fluoroscopic imaging of the oropharynx, hypopharynx, etc.

BACKGROUND OF THE INVENTION

The oropharyngeal physiology involved in a normal swallow is an exceedingly complex series of coordinated actions. A host of very different medical conditions, both physical and neurological in nature, can alter normal swallowing. For example, patients suffering stroke, Alzheimer's disease, amyotrophic lateral sclerosis, or traumatic brain injury can exhibit abnormal swallowing. In many instances, the abnormal swallow can and does cause aspiration of food material, both liquids and solids, into the lungs. This is especially prevalent (and life-threatening) in bed-ridden patients. Aspiration of foreign material into the airways leads to increased morbidity in hospitalized patients and can lead to pneumonia. Abnormalities in the human swallow, whether or not the condition results in aspiration of foods, is called dysphagia.

A normal human swallow can be separated into four semi-distinct phases: 1) oral preparation; 2) the oral phase; 3) the pharyngeal phase; and 4) the esophageal phase. Patients who have suffered a stroke, traumatic brain injury, or neuromuscular disorder (such as MS or ALS) have an increased risk of aspiration, and may have difficulty with the oral phase, the pharyngeal phase, or both. For instance, weak and/or uncoordinated muscle movement when chewing, or in the initial oral phase of swallowing, can cause food to fall into the pharynx and into the open airway. This often occurs before the completion of the oral phase of swallowing. Or impaired propulsion can result in residue in the oral cavity, valleculae, or pharynx after the swallow, when the residue may be inhaled into the trachea. Or a delay in the onset of the pharyngeal swallowing response can result in food falling into the airway during the delay when the airway is open. Or reduced peristalsis in the pharynx can leave residue in the pharynx after the swallow is completed that can fall or be inhaled into the airway. Additionally, laryngeal or cricopharyngeal dysfunction can also lead to aspiration because of decreased closure of the airway during swallowing. Any of these conditions, or a combination of these conditions, can lead to aspiration of food into the airways.

To detect and evaluate patients who have dysphagia or are at risk of developing dysphagia, speech pathologists currently employ a roughly standard procedure for initially evaluating a patient's swallow. A bedside swallow exam performed by most speech pathologists first evaluates the patient's medical history, respiratory status, level of responsiveness, and level of cognitive impairment, if any. Evaluating swallowing can be especially difficult in patients with moderate to advanced cognitive impairment due to the inability of the patient to understand and to follow instructions.

A physical examination of the oropharynx is then performed. The muscles involved in mastication, the lips, the tongue, and the palate are examined. The position of the patient when tested (prone, seated, standing) is noted as this can have a profound effect on the swallowing mechanism. The patient's empty mouth (“dry”) is evaluated. The patient is then asked to swallow one or more thin liquids, thick liquids, pureed textured, and/or solid textured foods to evaluate the swallow mechanism. In particular, the speech pathologist looks for a host of telltale signs of dysphagia such as gurgling, impaired vocal quality post-swallow, coughing, nasal regurgitation, and multiple swallows, as well as any visible signs that may indicate risk for aspiration.

While the standard bedside swallow exam to screen patients is beneficial for evaluating patients at risk for dysphagia, it sheds very little light on the whether the patient is actually aspirating and even less light on where in the swallow cycle the defect arises. Many patients, due to concomitant neurological defects, will silently aspirate, giving no indication during the bedside exam as to their condition. Aspiration in dysphagic patients, however, can be detected using a modified barium swallow fluoroscopic examination. Video fluoroscopy of the swallow mechanism is performed regularly to elucidate more clearly the anatomical or neurological deficit causing the dysphagia.

Dynamic fluoroscopic evaluation of the swallow, however, is not without its attendant difficulties and shortcomings. For instance, the imaging compositions conventionally used for fluoroscopic exams are thick suspensions of barium sulfate. Barium is employed because of its large X-ray absorption cross-section, which makes it radio-opaque. The use of barium sulfate suspensions as a radiological contrast medium has a number of drawbacks. A first drawback is that conventional barium sulfate suspensions generally have either poor adhesion to the walls of the oropharynx or too much adhesion. These compositions, having been initially designed to image the gastrointestinal tract, have not been altered much, if any, for use in imaging the mouth and throat. If the walls of the oropharyngeal tract are not sufficiently coated with the contrast agent, an X-ray image cannot be generated; there simply is not enough contrast to visualize the relevant structures. Conversely, if the suspension is made thicker to encourage adhesion, the thick, chalky suspension actually coats the mouth and throat and physically alters the movement of the muscles used for swallowing. Consequently, the image generated is not necessarily indicative of the true swallow response exhibited by the patient. Further, total clearance of material from the oropharyngeal and esophageal cavities would be a useful visual cue to determine whether the function of these structures is within normal limits. If the oropharynx is coated with too much contrast agent, the dense X-ray cross-section creates a complete opacity in the resultant X-ray exposure, which does not provide sufficient detail of the structures involved in swallowing. A complicating factor is the taste and chalky texture of barium suspensions, which makes them generally unpleasant to hold in the mouth and to swallow. Substances that are more food-like in taste and texture would more likely elicit a more representative swallow response.

See, for example, U.S. Pat. No. 4,020,152 to Heitz, which describes barium titanate and barium zirconate X-ray contrast agents. This patent specifically notes that it is quite difficult to generate fluoroscopic images of the oropharyngeal cavity. Heitz states that patients have great difficulty in holding a mouthful of contrast medium at the very back of their throats for a long time without swallowing. When the patient swallows the barium sulfate suspension, it slides over the mucous membranes, often without leaving sufficient contrast agent in place to generate an image. Heitz believes the lack of adhesion is due to the saliva covering the walls of the oropharynx, which substantially reduces the adherence of a barium sulfate suspension. As a result, radiological examination of this key physiological intersection, the junction where aspiration occurs, is difficult and often leads to only mediocre imaging. Failure to generate a clean radiological image of the swallow leads to imprecise diagnosis and treatment.

Moreover, once a patient has been diagnosed as having dysphagia and is known to be aspirating foods, some compensatory treatment must be implemented to prevent further aspiration. One method widely employed is to alter the consistency (i.e., the viscosity) of liquid foods. Thickened liquid foods are thought to inhibit aspiration by providing greater mechanical resistance to the muscles involved in swallowing and providing greater “mouthfeel” to the patient. See, for example, U.S. Pat. No. 5,932,235, to Ninomiya et al.: This patent describes a jellied preparation containing carrageenan, locust bean gum, and a polyacrylic acid. The preparation can be used to thicken liquid foodstuffs.

In hospital, nursing home, and clinical settings, thickened liquids deemed to be “nectar thick” or the more viscous “honey thick” are used to feed dysphagic patients. For instance, preferred liquid foods such as milk, coffee, or tea are thickened with an added thickening agent prior to being fed to a dysphagic subject. However, there has not been implemented any objective set of criteria to define the levels of thickness/viscosity which constitute a nectar thick composition versus a honey thick composition. The health provider simply thickens the desired food to a subjective thickness and provides it to the patient. This lack of standardization fosters great variability in practice. In short, individual speech pathologists, dieticians, food service managers, and food manufacturers arbitrarily determine, based upon their own subjective evaluation, what constitutes a nectar thick composition and a honey thick composition. In the vast majority of instances, no objective measurement of the increased viscosity of the modified food is taken. If a measurement is taken, it is done using rough, empirical evaluations of viscosity, such as the Line Spreading Test (LST), a test developed in the 1940s to gauge the consistency of foods. See Grawemeyer, E. A. and Pfund, M. C. (1943) “Line spread as an objective test of consistency,” Food Research 8:105-108. This greatly hinders gathering detailed information on the efficacy of using thickened liquids in the treatment of dysphagia.

Therefore, there continues to be a long-felt and unmet need in the study of dysphagia for a viscosity-standardized set of edible compositions for both the gross evaluation of dysphagia and for a corresponding viscosity-standardized set of edible compositions containing a radio-opaque agent for use in the radiographic imaging of the mouth and throat.

SUMMARY OF THE INVENTION

A first embodiment of the invention is directed to a kit of individual viscosity-standardized edible solutions for evaluating human subjects for dysphagia. The kit comprises at least two solutions, the two solutions being selected from the following group: a first edible solution having a known viscosity of from about 1 cp to about 60 cp at about 23° C., the first edible solution disposed in a first container; a second edible solution having a known viscosity of from about 300 cp to about 2000 cp at about 23° C., the second edible solution disposed in a second container; and a third edible solution having a known viscosity equal to or greater than about 3000 cp at about 23° C., the third edible solution disposed in a third container.

In alternative formulations of the first embodiment, the kit may contain a second edible solution having a viscosity of between about 300 cp to about 500 cp or between about 500 cp to about 1500 cp. In the preferred formulation, the third edible solution as described in the immediately preceding paragraph has a viscosity of between about 3000 cp to about 5000 cp, and more preferably still between about 3000 cp to about 4000 cp.

A second embodiment of the invention comprises the kit as described in the two preceding paragraphs, wherein the first, second, and third edible solutions comprise an imaging agent. It is preferred that the imaging agent comprises a radio-opaque imaging agent, preferably a barium-containing compound, and more preferably still a barium sulfate-containing compound.

The kit may also comprise, instead of solutions, compositions of matter that are capable of being diluted to yield viscosity-standardized edible solutions as described hereinabove. Thus, such a kit comprises at least two compositions of matter selected from the group consisting of a first composition capable of yielding upon dilution a first edible solution having a known viscosity of from about 1 cp to about 60 cp at about 23° C.; a second composition capable of yielding upon dilution a second edible solution having a known viscosity of from about 300 cp to about 2000 cp at about 23° C.; and a third composition capable of yielding upon dilution a third edible solution having a known viscosity equal to or greater than about 3000 cp at about 23° C.

A third embodiment of the invention is directed to a corresponding method for using the above-described kits to evaluate a human subject for dysphagia. The method comprises the steps of providing at least two of the first, second, and third edible solutions as described hereinabove. Then swallowing in the subject is evaluated for indications of dysphagia during and after the subject swallows one of the edible solutions and then during and after the subject swallows another of the edible solutions (i.e., one of the solutions having a different viscosity from the first solution swallowed). Because the two solutions have different, but known and standardized viscosities, by comparing the swallowing dynamics exhibited by the subject during ingestion of the two solutions, a more accurate diagnosis of the subject can be made. Additionally, because the solutions have a standard viscosity, the swallowing dynamics of two different subjects or between different populations of subjects can be compared accurately.

In the preferred formulation of the method, the edible solutions comprise a radio-opaque imaging agent that does not leave an artificial coating in the mouth and oropharynx after swallowing is complete. Swallowing by the subject is preferably evaluated by radiography.

In both the kit and the corresponding method, it is preferred that the edible solutions comprise a tasty and familiar base liquid vehicle, such as a non-pulpy fruit juice, or a liquid that has been treated to have an identifiable food flavor. The vehicle is adjusted to the required viscosity by adding a thickening agent thereto. Apple juice is the preferred vehicle. Because the solutions use a vehicle having a familiar taste, far more useful information is generated regarding the swallowing defects exhibited by the patient because the patient tends to swallow more naturally. This is not the case when a patient is offered a contrast solution that has an offensive taste, odor, or consistency.

The utilities of the subject compositions and methods are several-fold. A primary utility is that by using standardized solutions, consistency in treating dysphagia is promoted. Rather than supplying patients an arbitrarily thickened food or X-ray imaging product, the patient is supplied a solution of known viscosity. The patient's ability to swallow the solution properly (e.g., without aspiration, retention, regurgitation, and the like) is then evaluated, either by a gross physical exam or radiographic means or other visualization means, including X-ray, magnetic resonance imaging, and the like. Using two or more viscosity-standardized solutions allows the results of two (or more) distinct swallowing studies (e.g., one using the first solution, the other using the second solution) to be compared and contrasted. Moreover, it allows the results from different patients to be compared directly, without variations in the viscosity of the edible solutions introducing uncontrolled variables into the comparison.

The solutions described herein are useful in radiographic imaging of the mouth because they taste more food-like than conventional barium-containing imaging agents and are therefore more palatable. The specific viscosities recited herein for the solutions also promote the proper amount of adhesion between the solutions and the mucus membranes lining the mouth and throat. Consequently, the solutions tend to deposit a sufficient amount of imaging material on the mucus membranes to generate a radiographic image, but do not deposit so much imaging material as to change the swallowing dynamics of the patient under study, nor to leave an artificial coating after swallowing is complete. This is a distinct improvement over conventional barium agents, whose thick, chalky consistency is neither palatable, nor conducive to the generation of good radiographic images of the throat and mouth.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph depicting the line spread distance versus the apparent viscosity for a population of pre-thickened edible solutions. The sample volume used to generate each data point was 50 mL. [0022]
FIG. 2 is a graph depicting the line spread distance versus the apparent viscosity for a population of pre-thickened edible solutions. The sample volume used to generate each data point was 100 mL.[0023]

DETAILED DESCRIPTION

When speech pathologists thicken liquids, one of the properties they are changing is viscosity. Liquids may be described by several properties, including viscosity, density, and elastic parameters, among others. As described herein, standardized solutions for evaluating dysphagia are characterized using viscosity, as measured with a viscometer, as a key parameter. In simple terms, the torque required to rotate a spindle immersed in the solution is measured. As discussed in detail by Li et al (1992) [0024] Dysphagia 7:17-30, viscous liquids are classified as either Newtonian or non-Newtonian. A Newtonian liquid flows at a rate which is directly proportional to the applied shear force while a liquid not obeying this proportionality is deemed to be non-Newtonian.
The complexity and cost of viscometers makes them impractical for dietitians and speech pathologists to utilize in most clinical settings. Therefore, clinicians often resort to simpler means of generating a rough estimate of viscosity, such as the line spread test (LST) as a practical alternative to characterizing the viscosity of thickened liquids. [0025]
The LST was originally developed in the 1940's as a simple tool to measure food “consistency.” See 8. Grawemeyer & Pfund (1943)[0026] Food Research 8:105-108, and Adams & Birdsall (1946) Food Industries 78-80. The LST measures the “flow” of a food/liquid by placing a standard amount of food/liquid in a cylinder, lifting the cylinder and allowing the food/liquid to flow on a horizontal surface for 1 minute and then measuring the distance it has spread. The simplicity of this tool is extremely appealing in clinical practice to measure objectively the general consistency of thickened liquids. As described in the Examples, the LST can roughly distinguish between the viscosity of pre-thickened liquids, and may be a first step toward establishing the utility of this tool in clinical practice.
However, the LST is not overly discriminating as a tool to measure viscosity. Thus, the principal object of the invention is to provide a set or kit of solutions of known and standardized viscosity. The solutions in the kit come pre-made, as ready-to-use liquids, or in pre-measured dry powders or gels that can then be diluted with an appropriate liquid vehicle to yield solutions of the required viscosity. [0027]
The first embodiment of the invention is a pair of viscosity-standardized solutions for evaluating dysphagia in human subjects. Specifically, at least two edible solutions are required, the two solutions being selected from among: a first solution having a viscosity of between about 1 and 60 cp, a second solution having a viscosity of between about 300 and 2000 cp, and a third solution having a viscosity great than about 3,000 cp. [0028]
Viscosity of the compositions is measured at room temperature, generally about 23° C., and can be determined using any number of conventional and commercially available spindle-type viscometers, such as those manufactured by Brookfield Engineering Laboratories, Middleboro, Mass. Brookfield's instruments use a rotating spindle immersed in the fluid to measure viscosity. Brookfield's instruments are of the cone-and-plate rheometer-type design and are ideal for measuring the viscosity of non-Newtonian fluids at low shear rates. The preferred instrument from among Brookfield's offerings is Model LVDV1+, an 18-speed model with digital readout. Viscometers and their operation are widely known and will not be described in great detail herein. For detailed information regarding Brookfield's Model LVDV1+ viscometer, see Brookfield's Manual No. M/92-021-M0101, available from the manufacturer and also on-line at www.brookfieldengineering.com. For detailed information regarding measuring viscosity, see Li et al, supra, and Brookfield's technical manual entitled “More Solutions to Sticky Problems” (also available at www.brookfieldengineering.com). [0029]
For radiographic imaging of the mouth and throat, it is preferred that compositions having the above-noted viscosities are formulated using a liquid base vehicle having an identifiable food flavor, such as a juice flavor or honey, chocolate, vanilla, etc. Apple juice is particularly preferred a base vehicle. Apple juice is very advantageous for this purpose because it is widely available, relatively inexpensive, and pulp-free. It is quite palatable and familiar to virtually everyone, and can be stored and transported as a concentrate. The liquid base can be naturally or artificially flavored, and can also contain additional components such as colorants, preservatives, and the like. To the liquid vehicle is added a thickening agent and/or a radio-opaque imaging agent. Because a suspension of radio-opaque material will, by itself, increase the viscosity of a thin liquid to within the above-noted viscosities, depending upon the nature of the suspension used, a thickening agent may not be required to arrive at solutions having the desired viscosity. [0030]
Any other type of non-pulpy juice, liquid, or water may be used as the vehicle. A fruit juice is much preferred as the vehicle, however, because of its familiar taste and aroma. An ultimate goal of the invention being an accurate evaluation of the patient's true swallowing dynamics, presenting an imaging composition which is as closely simulative as possible to a food the patient would normally ingest and enjoy is highly desirable. [0031]
The preferred thickening agent for use in the present invention is a commercially available preparation marketed by Novartis (Basel, Switzerland) under the registered trademark “THICKENUP.” While the “THICKENUP” formulation is preferred, any suitable food thickener (e.g., “THICK IT”-brand thickener (Milanti Co.) starch, sugars, glycols, etc., may be used). [0032]
The preferred radio-opaque imaging agent is a suspension of barium sulfate. Suitable barium sulfate and barium sulfate suspensions are available commercially from numerous sources. Preferred commercially available barium sulfate and edible suspensions thereof can be obtained from the E-Z-EM Corporation, Westbury, N.Y. Specifically preferred are the products bearing E-Z-EM catalog nos. L147, L164, L168, and L178 (liquid barium sulfate suspensions), catalog no. 764 (high density barium sulfate suspension), and catalog no. 745 (bulk barium sulfate for suspension). Particularly preferred for use in both the first and second solutions is “EnteroH” brand barium suspension (catalog no. L147), from E-Z-EM. [0033]
It is critical when formulating the compositions to include the proper amount of imaging agent and/or thickener because both components will contribute to the ultimate viscosity of the composition and there must also be the proper amount of imaging agent present in the composition to generate useful radiographic images (when an imaging agent is used). If there is too little imaging agent, the composition will be invisible to X-rays, if there is too much imaging agent, the composition will be too opaque. [0034]
For the first solution, the preferred formulation is as follows: [0035]
Commercially purchased apple juice at room temperature, (single-strength, about 6.5 to 7.0 brix, at about 23° C.), 140 mL, is admixed with 90 mL of “Entero H” brand barium sulfate suspension, available commercially from E-Z-EM. The mixture is thoroughly agitated until uniform. To ensure consistency of application, it is much preferred that the composition be made no more than 2.5 hours before use. The formulation should be administered at room temperature. This formulation yields a low-viscosity composition of about 25 cp. [0036]
For the second solution, the preferred formulation is as follows: [0037]
Commercially purchased apple juice at room temperature, (single-strength, about 6.5 to 7.0 brix, at about 23° C.), 30 mL, is admixed with from about 170 to about 400 mL of “Liquid Polibar” brand barium sulfate suspension, available commercially from E-Z-EM corporation. The mixture is thoroughly agitated until uniform. To ensure consistency of application, it is much preferred that the composition be made no more than 2.5 hours before use. The formulation should be administered at room temperature. This yields a solution having a viscosity of from about 300 to about 2000 cp. [0038]
For the third solution, the preferred formulation is as follows: [0039]
Commercially purchased apple juice at room temperature, (single-strength, about 6.5 to 7.0 brix, at about 23° C.), 120 mL, is admixed with about 50 mL (3 tablespoons) of “THICKENUP” brand thickener. (As sold commercially, the “THICKENUP” thickener includes a sliding measuring spoon.) The juice and thickener mixture is agitated thoroughly and allowed to sit undisturbed for no less than 10 minutes. To this mixture is added about 92 mL of “Liquid Polibar” brand barium sulfate suspension, available commercially from E-Z-EM Corporation. The mixture is again thoroughly agitated until uniform. To ensure consistency of application, it is much preferred that the composition be made no more than 2.5 hours before use. The formulation should be administered at room temperature. This yields a solution having a viscosity of about 3000 cp. [0040]
For radiographic imaging purposes, the patient is positioned laterally before a suitable fluoroscopic device and asked to swallow one or more of the three compositions. A video fluoroscope and suitable recording equipment are then used to visualize and record the passage of the composition through the mouth and throat during and after swallowing. If desired, the study can be performed using any combination or both of the two edible solutions. [0041]

EXAMPLE

The following Example is included herein solely to provide a more complete and consistent understanding of the invention disclosed and claimed herein. The Example does not limit the scope of the invention in any fashion. [0042]
Materials: [0043]
The Example explores whether pre-thickened liquids (from Novartis Nutrition, Minneapolis, Minn.), whose viscosity has first been measured with a viscometer, can reliably be separated into “nectar” and “honey” categories using the Line Spread Test. According to Novartis' manufacturing standards, nine (9) of the samples tested were designated as “nectar” and then (10) of the samples tested were designated as “honey” (19 samples total). The 19 samples were first examined using a Brookfield viscometer, and then evaluated using the Line Spread Test (LST). [0044]
Viscosity Measurements: [0045]
Each sample was tested using either a Brookfield HVT or LVT rotational viscometer (Brookfield Engineering, Stoughton, Mass.). The sample to be measured was contained in either the small sample chamber provided by Brookfield or a 600 ml Griffin low-form beaker, depending on the spindle/chamber arrangement appropriate for each sample (for details on equipment for viscosity measurement using these two Brookfield instruments, see “More Solutions to Sticky Problems,” available from Brookfield Engineering). The shear rate and apparent viscosity of the non-Newtonian liquids were estimated using the method described by Li et al. (1992) [0046] Dysphagia 7:17-30. (Note that while Newtonian liquid viscosity is a constant, regardless of liquid flow rate, non-Newtonian liquid viscosity is not. The “apparent viscosity” describes the instantaneous viscosity at a given rate of flow). For uniformity between different fluids, the apparent viscosity for each fluid was computed at a shear rate of approximately 15 sect⁻¹. For the remainder of this Example, the term “viscosity” refers to “apparent viscosity at a shear rate of 15 sec⁻¹,” unless otherwise noted.
Line Spread Test: [0047]
The standard LST, Mann & Wong (1996) [0048] J Am. Diet. Assoc. 96:585-588, was carried out on a counter top using a piece of Plexiglas with a template of pre-measured concentric circles spaced 0.25 inches (0.64 cm) apart placed beneath it. The counter top was confirmed to be level with a carpenter s level. A PVC pipe, with an internal diameter of 2 inches (5.08 cm) was positioned in the middle of the template and filled with 50 ml of the sample to be tested. The tube was lifted and the sample was allowed to spread for 1 minute. Measurements of the diameter of the spreading sample were taken at 90-degree increments and averaged. to give the line spread reading. This test was carried out three times to get an average line spread reading. For the Example, the LST was also carried out using a 100 ml sample size to explore how volume might affect the line spread results.
Statistical Analyses: [0049]
For both LST and viscosity values, group means were computed for nectar and honey consistencies and differences between the two categories tested using Student's t-test. To study the separation between nectar and honey consistencies further, a linear-discriminant analysis was performed. This analysis generates a classification rule to categorize each liquid into the nectar or honey group based on its LST value. The rule is generated by maximizing the difference between the two groups in a least squares sense. Each value in the data set is then tested using the rule and the number of errors in classification was determined. Statistical analyses were computed automatically using the SAS statistical program (The SAS Institute, Cary, N.C.). [0050]
Results: [0051]

Group values for the LST and viscosity are presented in Table 1 (mean+SD). There was a highly significant difference in line spread test results (both 50 and 100 ml) and viscosity values between nectar and honey consistencies (p<0.0001 by Student's t-test).

TABLE 1


Category	Viscosity @ 15 ^s−1	LST (50 ml)	LST (100 ml)

Nectar	358.61 ± 77.9	12.67 ± 0.829	20.06 ± 1.45
Honey	1245.10 ± 357.4*	9.25 ± 0.50*	15.04 ± 0.73*

FIGS. 1 and 2 show line spread distance plotted as a function of viscosity for line spread volumes of 50 ml (FIG. 1) and 100 ml (FIG. 2). The first observation is that the LST discriminates very well between different classes of liquids. That is, the LST clearly differentiates between the nectar versus honey consistencies in the present study. As is clearly shown in both FIGS. 1 and 2, these pre-thickened nectar and honey liquids fall into distinct categories, in terms of both line spread values and viscosity, in both the 50 ml and 100 ml test volumes. [0053]
The classification rules computed from the discriminant analysis may be expressed as the line spread value that separates nectar and honey categories for each volume of sample tested. These separating line spread values are: 10.7 (50 ml sample, FIG. 1—horizontal dashed line) and 17.5 (100 ml sample, FIG. 2—horizontal dashed line). When the samples were re-tested based on this rule, there were no errors in classification, indicating that the line spread test does an excellent job of discriminating between these two broad categories of liquids. [0054]
Beyond the gross separation into nectar versus honey consistencies, however, there is no apparent predictive value of the line spread test for estimating apparent viscosity. In other words, it does not appear to be possible to assign a one-to-one relationship between apparent viscosity values and line spread test values. [0055]
Discussion: [0056]
The goal of this Example was to explore the utility of the Line Spread Test (LST) as an objective measure of thickened liquid consistency. Because increased viscosity is often associated with thickened liquids, line spread and viscosity values were compared to explore whether a relationship exists between the two tests. Two results emerge from this Example. On one hand, the LST was able to separate pre-thickened juices into nectar and honey categories unambiguously (i.e., with no errors), a separation also provided by viscosity measurement. On the other hand, within this restricted group of liquids, there was no relationship between line spread and viscosity values. In other words, there was no predictive value in terms of viscosity using the LST, apart from the overall separation into nectar and honey categories. Thus, the LST is not an accurate substitute for a viscosity-standardized solution; a solution whose viscosity is accurately known prior to being administered to the subject. [0057]
Based on these results, there are two possibilities concerning the relationship between LST values and viscosity values. One is that decreased line spread test values are associated with increased viscosity, but that the LST simply is not sensitive enough to detect differences in viscosity within a given category of liquids (i.e., viscosity differences within the nectar or honey categories). If this were true, however, it would be expected that an increase in the volume of test fluid from 50 to 100 ml would increase the sensitivity of the LST, and this was not found in the example (compare FIGS. 1 and 2). [0058]
A different possibility is that other fluid properties are altered along with viscosity, and that it is one or more of these other properties that are reflected in the LST values. Indeed, one of the difficulties in interpreting LST values is that several fluid properties possibly affect the final value. Density likely plays a role because the driving force for liquid spreading is provided by gravity; viscosity plays a role through the retarding frictional forces at the liquid-solid interface. Finally, elastic parameters, which relate to bolus “cohesiveness,” may also be important. [0059]
The role of elastic properties in the dynamics of the LST is also supported by a survey of the civil engineering literature. A commonly used measure to field test the consistency of freshly mixed concrete is called the “slump” test. See, for example, Schowalter & Christianson (1998) [0060] J. Rheol. 42(4):865-870. This test is carried out in the same manner as the LST, except that the height of the fluid pool after spreading is measured rather than the radius to which the material spreads. (Conservation of fluid volume may be used to relate the slump height to the line spread difference. The calculation is very simple and emphasizes the intimate link between these two tests.) Interestingly, this slump height has been shown to correlate with the “normalized yield stress” of the concrete mixture. Yield stress is a measure of fluid elasticity and in these analyses is normalized by density, emphasizing the multi-factorial nature of the physical process of spreading. Because concrete has a much higher yield stress than typical liquid foodstuffs, the slump test results are not directly applicable to the edible solutions described herein. However, the correspondence between the two tests suggests that yield stress and density are fluid properties which may affect the line spread distance.
Clearly the mechanical behavior of liquid foodstuffs is complex; even more complex are their interactions with the swallowing system. However, the situation remains that: 1) dietary modifications are a common treatment technique; and 2) there are no objective criteria for thickened liquid preparation for assessment and/or treatment. This has led to little inter-clinician agreement and reliability in terms of thickened liquid consistency. Therefore, there is a great need for a pre-made solutions, or kits that yield solutions, of known and consistent viscosity, thereby removing one source of uncertainty in the diagnosis and evaluation of dysphagia. [0061]

Claims

What is claimed is:

1. A kit of individual viscosity-standardized edible solutions for evaluating human subjects for dysphagia, the kit comprising at least two edible solutions selected from the group consisting of:

(a) a first edible solution having a known viscosity of from about 1 cp to about 60 cp at about 23° C., the first edible solution disposed in a first container;

(b) a second edible solution having a known viscosity of from about 300 cp to about 2000 cp at about 23° C., the second edible solution disposed in a second container; and

(c) a third edible solution having a known viscosity equal to or greater than about 3000 cp at about 23° C., the third edible solution disposed in a third container.

2. The kit according to claim 1, wherein the second edible solution has a viscosity of between about 300 cp to about 500 cp.

3. The kit according to claim 1, wherein the second edible solution has a viscosity of between about 500 cp to about 1500 cp.

4. The kit according to claim 1, wherein the third edible solution has a viscosity of between about 3000 cp to about 5000 cp.

5. The kit according to claim 1, wherein the third edible solution has a viscosity of between about 3000 cp to about 4000 cp.

6. The kit according to claim 1, wherein the second edible solution has a viscosity of between about 300 cp to about 500 cp, and the third edible solution has a viscosity of between about 3000 cp to about 5000 cp.

7. The kit according to claim 1, wherein the second edible solution has a viscosity of between about 500 cp to about 1500 cp, and the third edible solution has a viscosity of between about 3000 cp to about 5000 cp.

8. The kit according to claim 1, wherein the second edible solution has a viscosity of between about 300 cp to about 500 cp, and the third edible solution has a viscosity of between about 3000 cp to about 4000 cp.

9. The kit according to claim 1, wherein the second edible solution has a viscosity of between about 500 cp to about 1500 cp, and the third edible solution has a viscosity of between about 3000 cp to about 4000 cp.

10. The kit according to claim 1, wherein the first, second, and third edible solutions comprise an imaging agent.

11. The kit according to claim 10, wherein the imaging agent comprises a radio-opaque imaging agent.

12. The kit according to claim 11, wherein the radio-opaque imaging agent comprises a barium-containing compound.

13. The kit according to claim 11, wherein the radio-opaque imaging agent comprises barium sulfate.

14. A method for evaluating a human subject for dysphagia, the method comprising:

(a) providing at least two edible solutions selected from the group consisting of:

(i) a first edible solution having a known viscosity of from about 1 cp to about 60 cp at about 23° C., the first edible solution disposed in a first container;

(ii) a second edible solution having a known viscosity of from about 300 cp to about 2000 cp at about 23° C., the second edible solution disposed in a second container; and

(iii) a third edible solution having a known viscosity equal to or greater than about 3000 cp at about 23° C., the third edible solution disposed in a third container; and then

(b) (i) evaluating swallowing in the subject for indications of dysphagia during and after the subject swallows one of the edible solutions; and

(ii) evaluating swallowing in the subject for indications of dysphagia during and after the subject swallows another of the edible solutions.

15. The method according to claim 14, wherein in step (a) the first, second, and third edible solutions comprise a radio-opaque imaging agent that does not leave an artificial coating in the mouth and oropharynx after swallowing is complete; and in steps (b)(i) and (b)(ii), swallowing is evaluated by radiography.

16. The method according to claim 14, wherein the first, second, and third edible solutions comprise a non-pulpy fruit juice wherein viscosity of the fruit juice is modified by adding a thickening agent thereto.

17. The method according to claim 16, wherein the fruit juice is apple juice.

18. The method according to claim 14, wherein the first, second, and third edible solutions comprise an imaging agent.

19. The method according to claim 18, wherein the imaging agent comprises a radio-opaque imaging agent.

20. The method according to claim 19, wherein the radio-opaque imaging agent comprises a barium-containing compound.

21. The method according to claim 19, wherein the radio-opaque imaging agent comprises barium sulfate.

22. A kit of compositions of matter, the compositions capable of being diluted to yield viscosity-standardized edible solutions for evaluating human subjects for dysphagia, the kit comprising at least two compositions of matter selected from the group consisting of:

(a) a first composition capable of yielding upon dilution a first edible solution having a known viscosity of from about 1 cp to about 60 cp at about 23° C.;

(b) a second composition capable of yielding upon dilution a second edible solution having a known viscosity of from about 300 cp to about 2000 cp at about 23° C.; and

(c) a third composition capable of yielding upon dilution a third edible solution having a known viscosity equal to or greater than about 3000 cp at about 23° C.

23. The kit according to claim 22, wherein the first, second, and third edible solutions comprise an imaging agent.

24. The kit according to claim 23, wherein the imaging agent comprises a radio-opaque imaging agent.

25. The kit according to claim 24, wherein the radio-opaque imaging agent comprises a barium-containing compound.

26. The kit according to claim 24, wherein the radio-opaque imaging agent comprises barium sulfate.