Dysphagia
Conditions
Brief summary
This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.
Detailed description
1. All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study. 2. The participant's neck's physical dimensions and the device's physical dimensions will be measured and recorded. A physical examination including carotid artery auscultation will be performed. 3. After the application of local lidocaine, the high-resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the entire pharynx from the nasopharynx to the proximal esophagus. In this position, manometry recording of the entire pharynx will be possible. 4. The pharyngeal exerciser will be placed around the neck overlying the larynx. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of the neck. 5. Patients will be sitting in an upright position and acclimatized for 10 minutes before proceeding. 6. Each subject will perform the following swallows: 7. Dry swallows x 5 times. 5 ml and 10 ml- of water swallows at room temperature x 5 times each. 5 ml and 10 ml- mashed potato swallowed at room temperature x 5 times each. 8\. The sequence of the swallow types will be randomized. The swallow will be performed under device pressure of zero, 20, 30, 40 and 60 mm Hg in a randomized fashion. Each swallow type will be repeated 5 times with 30-second intervals in between. 9\. The externally applied pressure will be measured by means of the pressure gauge included in the device 10\. All the subjects will be given the option to participate in the concurrent videofluoroscopic examination along with pharyngeal manometry 11\. The fluoroscopy machine will be turned on for 5 seconds only during the swallowing. The rest of the time fluoroscopy machine will be turned off. 12\. These subjects undergoing concurrent fluoroscopy and manometry will perform the following swallows at zero, 20, and 40 mm Hg of device pressure: Dry swallows x 3 times. 5 ml and 10 ml of water mixed barium swallow at room temperature x 3 times each. 5 ml- mashed potatoes mixed with barium at room temperature x 3 times. The participant will also be instructed to resume their regular diet and activity. All the tracings and video recordings will be analyzed by two individuals in a blinded fashion.
Interventions
Pharyngo-esophageal manometry during lateral fluoroscopy
Sponsors
Study design
Intervention model description
Study of healthy subjects
Eligibility
Inclusion criteria
* Healthy volunteers must be at least 18 years of age or older.
Exclusion criteria
* Subjects with cervical spine disorders. * Subjects with neurological disorders like dementia, cerebrovascular diseases other than Parkinson's Disease * Subjects with carotid artery bruit or carotid vascular disorders. * Subjects suffering from muscle diseases like muscular dystrophies, myopathies. * Subjects with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders. * Subjects with any current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation. * Subjects cannot have previous head or neck surgery or radiation. * Subjects unable to tolerate nasal intubation. * Subjects with significant bleeding disorders for whom nasal intubation has been deemed contraindicated. * Subjects with a known upper airway or esophageal obstruction preventing the passage of the manometry probe. * Subjects with autonomic dysfunction. * Subjects having a history of allergy to lidocaine and barium. * Subjects who are pregnant or lactating. * Subjects who have advanced medical disorders (e.g.: chronic obstructive pulmonary disease (COPD), congestive heart failure, cirrhosis, cancer, chronic renal failure, etc.). * Subjects who are medically unstable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| laryngeal excursion during swallowing | During mano-fluorography procedure | maximum laryngeal excursion from resting position measured from fluoroscopic images during swallowing |
| hyoid excursion during swallowing | During mano-fluorography procedure | maximum hyoid bone excursion from resting position measured from fluoroscopic images during swallowing |
| upper esophageal sphincter (UES) opening during swallowing | During mano-fluorography procedure | maximum UES anterior-posterior diameter measured from fluoroscopic images during swallowing |
| pharyngeal peak peristaltic pressure | During mano-fluorography procedure | maximum deglutitive pressure within the pharynx |
| pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration | During mano-fluorography procedure | manometric duration of peristaltic pressure wave in velopharynx, oropharynx and hypopharynx |
| pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral | During mano-fluorography procedure | space-time and length integral of pharyngeal pressures in the velopharynx, oropharynx and hypopharynx |
| hypopharyngeal intrabolus pressure | During mano-fluorography procedure | maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx |
| hypopharyngeal intrabolus duration | During mano-fluorography procedure | duration of maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx |
| UES nadir pressure | During mano-fluorography procedure | minimum pressure within the upper esophageal sphincter (UES) during UES deglutitive relaxation |
| UES relaxation time | During mano-fluorography procedure | duration pressure drops within the upper esophageal sphincter during UES deglutitive relaxation |
| baseline UES pressure | During mano-fluorography procedure | average UES pressure when no swallow activity is present |
Countries
United States