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Pill Swallowing by Adults with Dysphagia

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Pill Swallowing by Adults with Dysphagia ORIGINAL ARTICLE Pill Swallowing by Adults With Dysphagia Giselle Carnaby-Mann, B App Sci, PGrad Dip (HSc), MPH, PhD; Michael Crary, PhD Objective: To evaluate differences in swallowing Results: Significant differences included greater physiology and safety in patients with dysphagia sEMG amplitude and longer apneic duration when between conventional tablets and a new method of swallowing a conventional tablet compared with the tablet transportation, orally disintegrating technology ODT (PϽ.001). Patients with dysphagia demonstrated (ODT) (RapiTab; Schwarz Pharma Inc, Milwaukee, significantly longer total swallow durations (PϽ.001), Wis). a higher number of swallows per tablet (PϽ.002), and the need for fluid to assist in the clearance of the con- Design: The study observed a single group, crossover ventional tablet (PϽ.001). No significant difference design. was noted between the 2 tablet preparations in amount of residue or airway compromise during or Setting: Outpatient clinic within an academic teaching following the swallow. On a postevaluation survey, hospital. patients reported that they preferred the ODT prepara- tion for most of the parameters assessed. Participants: A total of 36 adult dysphagic patients re- ferred to the clinic. Conclusions: Patients with dysphagia frequently com- plain of trouble swallowing medication. In this study, an Interventions: All subjects underwent simultaneous ODT formulation provided a method of delivery that re- nasopharyngeal endoscopic evaluation, surface elec- quired less effort to swallow, did not result in increased tromyographic (sEMG) measurement, and respiratory levels of airway compromise, and was preferred by dys- monitoring during swallowing. Subjects were evalu- phagic patients. The ODT medication delivery technol- ated swallowing the ODT and a conventional tablet ogy may provide benefit to adults with dysphagia in con- formulation. Tablets were randomly and blindly pre- venience, compliance, and accuracy of dosing. sented to each subject. Subjects completed a prefer- ence survey subsequent to swallowing both tablets. Arch Otolaryngol Head Neck Surg. 2005;131:970-975 YSPHAGIA (DIFFICULTY persistent challenge for many individuals. swallowing food or liq- A recent national survey revealed that over uids) is a common con- 40% of adults in the general community ex- sequence of many health perience problems swallowing pills.3 Of problems and has been adults who reported difficulty swallowing Dassociated with complications such as pills, 14% disclosed that they had delayed pneumonia, dehydration, and malnutri- taking a dose of their medication, and 8% tion. Dysphagia is currently estimated to had skipped a dose completely. Thus, adults affect more than 18 million adults in the who have difficulty swallowing these forms United States,1 and it has been proposed of oral medications may not comply with that this number is likely to rise in the near prescribed regimens. Poor compliance with future owing to the aging population and oral medication regimens may be elevated a reported association between advanc- in the patient with dysphagia. For example, ing age and swallowing difficulties.2 With 15% of all residents in surveyed long-term impaired swallowing, many patients dem- care facilities reported difficulty swallow- onstrate difficulty in transporting sub- ing tablets and capsules. Of this group, 5% stances from the mouth into the phar- regularly expectorated this medication, ynx. Hesitation, impaired control of oral while 27% did not even attempt to swallow materials, incomplete clearance or ex- these medications.4 Patients with dyspha- Author Affiliations: tended clearance time for swallowed ma- giawhofailtocomplywithprescribedmedi- Departments of Psychiatry, terial, and penetration or aspiration of cation dosing are likely to encounter in- McKnight Brain Institute (Dr Carnaby-Mann) and swallowed materials into the airway are all creased morbidity and mortality. Thus, Communicative Disorders common features of a dysphagic profile. health care providers must improve meth- (Dr Crary), University of Swallowing oral medications in the form ods to effectively deliver oral medications Florida, Gainesville. of pills, tablets, or capsules also presents a to the swallowing-impaired patient. (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 131, NOV 2005 WWW.ARCHOTO.COM 970 ©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 Figure 1. Simultaneous data collection of conventional tablet swallowing. The image displays an example of synchronized data collection using the Kay Digital Swallowing Workstation and signals laboratory (model No. 7100; KayPENTAX, Lincoln Park, NJ). Recent developments in dosing technology offer an METHODS alternative delivery mechanism for medication to pa- tients with oropharyngeal swallowing problems.5,6 A form of orally disintegrating technology (ODT), DuraSolv SUBJECTS (Cima Labs Inc, Eden Prairie, Minn), which is used in the manufacture of RapiTab (Schwarz Pharma Inc, Mil- We recruited a consecutive sample of patients referred to an waukee, Wis), provides a means by which oral medica- outpatient swallowing clinic within an academic teaching hos- tions are delivered via rapid disintegration of a tablet pital between November 2003 and April 2004 for this study. within the mouth facilitating passage through the upper Adults 21 years or older with a complaint of swallowing diffi- culties based on patient and/or caregiver report were ap- aerodigestive system without the use of water to aid in proached for participation in the study. In total, 36 eligible pa- swallowing. Rapidly dissolving tablets may facilitate safer tients participated in this study. This study was approved by and more consistent delivery of medication to swallowing- the institutional review board of the University of Florida. compromised patients.7,8 However, advantages of this form of oral medication have not been established in swallow- ing-impaired adults. Information on the relative effec- PROCEDURES tiveness, safety, and preference of swallowed ODT prepa- rations is a prerequisite to clinical application of this form The study followed a randomized, single-group, crossover de- sign. All swallowing measurements were conducted using the of oral medication in adults with swallowing impair- 9,10 Kay Digital Swallowing Workstation and Swallowing Signals ments. Laboratory (model No. 7100; KayPENTAX, Lincoln Park, NJ). This study aimed to investigate differences in swal- The Kay Digital Swallowing Workstation with signals labora- lowing effectiveness and safety between ODT and con- tory is a computer-integrated system of swallowing measure- ventional tablet preparations in adults with swallowing ment facilities including videoendoscopy, cervical ausculta- impairments. In addition, it sought to evaluate prefer- tion, surface electromyography (sEMG), pharyngeal manometry, ence for either preparation. The primary null hypoth- and respiratory monitoring. The system is specifically de- esis for this study was that there would be no difference signed to evaluate swallowing and permits synchronization, on- in the success or safety of bolus clearance between ODT line display, recording, and digitization of several physiologic preparations and conventional pill or tablet formula- signals during the time of the swallowing evaluation. For this study, nasopharyngeal videoendosocopy was used to visually tions. Secondary null hypotheses were that there would display all swallowing attempts of each preparation (Figure 1). be no differences in the time to bolus clearance, route of Simultaneous sEMG was used to evaluate the timing and bolus clearance and/or position of residue, number of muscular effort of each swallow event, and simultaneous na- swallows, and effort attributed to swallowing the 2 for- sal airflow monitoring was used to measure the apneic dura- mulations. tion of swallowing associated with each preparation. (REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 131, NOV 2005 WWW.ARCHOTO.COM 971 ©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 MATERIALS NASAL AIRFLOW MEASURES Each subject was observed videoendoscopically while swal- Respiratory coordination for swallowing was measured using lowing 2 tablet preparations, RapiTab (an ODT) and a conven- a nasal catheter positioned at the entrance of each subject’s nare. tional tablet, both manufactured by Schwarz Pharma Inc. Both Respiratory information (inhalation/exhalation) displayed as tablet types had an average weight of 340 mg and thickness of a line tracing was recorded for all swallowing attempts. Respi- 4.05 mm. Each tablet preparation was colored blue to maxi- ration points were temporally related to the videoendoscopic mize visualization during the videoendoscopic study. Tablet physiology such as airway closure and reopening. Respiration order was randomly assigned from a computer-generated ran- measures derived included (1) onset of inspiration, defined as dom numbers list. The subjects and investigators were blind a downward line tracing associated with an open glottis posi- to the order of presentation of the tablet formulations. To en- tion on the endoscopic trace; (2) swallowing apnea, defined as sure blinding, each preparation was dispensed and arranged by a horizontal line on the respiratory tracing indicating absence the research assistant according to the randomization sched- of airflow; and 3) expiration onset,
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