Characterization of the Striated Esophagus (St.Eso) Deglutitive Motor Function and Its Modulation by Pharyngeal Phase Swallow Biomechanics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 557
- Locations
- 1
- Primary Endpoint
- hypopharyngeal intra-bolus
Study Overview
Brief Summary
The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.
Detailed Description
To achieve the specific aim, the investigators will use state-of the-art available techniques and recording modalities alone or in combination/concurrently, as well as a novel device with proven ability to non-invasively manipulate the pharyngeal biomechanics both in a positive as well as negative way. This device and technique have been described earlier in the innovation section.
High Resolution Manometry (HRM)/Impedance recording: Pharyngeal and proximal esophageal pressure phenomena will be recorded and analyzed using a high-resolution manometric catheter (36 sensors 1 cm spacing), positioned trans-nasally to traverse the pharynx, UES, and proximal esophagus passing the transition zone) and computerized recording and analysis system. Also, manometric data will be imported to a supplementary programming environment when computational tools provided in the conventional software do not meet our analytical needs. Also configured on the high-resolution manometric probe are 18 impedance sites spaced every 2 cm to monitor bolus position. Similar to the manometric data, impedance data is also displayed by the previously described recording and analysis systems.
Concurrent high-resolution impedance manometry and digital video-fluoroscopic recording: To obtain objective quantifiable measures of peristalsis, swallow biomechanics and bolus kinematics, the investigators use high resolution impedance manometry concurrent with 30 frame/sec digital videofluoroscopy. Since our catheter also has impedance recording it will provide opportunity for additional analysis in concert with fluoroscopic recordings.
Digital video-fluoroscopy: The investigators will use digital video fluoroscopy at 30 frame/s in the sagittal or frontal view to record and subsequently analyze the deglutitive laryngeal and hyoid excursions as well as UES opening and closure data and bolus trajectory and kinematics. Video-fluoroscopic recordings will be obtained at 90 kiloelectron volt, using a 9-in. image intensifier and appropriate collimation. Based on our preliminary studies, the investigators will record 5-ml and 10-ml liquid barium swallows. Fluoroscopic sagittal images will be targeted to clearly visualize the entire pharynx, larynx, hyoid bone, upper esophageal sphincter (UES) and the proximal esophagus. A pregnancy testing will be completed prior to fluoroscopy exposure.
Technique for reducing laryngeal and striated esophagus (St.Eso) excursion: the investigators will use the swallowing resistance exercise device (sRED) to experimentally reduce the laryngeal and St.Eso excursion and UES opening.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy subjects aged 18 to 90 years.
- •Patents with dysphagia but normal high resolution esophageal manometric findings defined by the Chicago classification.
Exclusion Criteria
- •Anyone less than 18 years old.
- •Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation.
- •Patients suffering from muscle diseases like muscular dystrophies, myopathies.
- •Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
- •Patients having history of allergy to lidocaine or barium.
- •Patients who are pregnant or lactating.
- •Patients who are medically unstable.
- •Patients who are unable to apply the exerciser independently or with the help of a caregiver.
- •Patients who lack cognition.
Arms & Interventions
Striated esophagus deglutitive motor function healthy adults
Testing of manometric, impedance and biomechanical measurements during swallowing in healthy volunteer adult subjects.
Intervention: Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction (Device)
Striated esophagus deglutitive motor function healthy adults
Testing of manometric, impedance and biomechanical measurements during swallowing in healthy volunteer adult subjects.
Intervention: Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device (Device)
Striated esophagus deglutitive motor function in patients with ineffective esophageal motility
Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with ineffective esophageal motility.
Intervention: Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction (Device)
Striated esophagus deglutitive motor function in patients with ineffective esophageal motility
Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with ineffective esophageal motility.
Intervention: Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device (Device)
Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry
Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with symptoms of dysphagia but "normal" esophageal manometry by the Chicago Classification criteria.
Intervention: Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction (Device)
Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry
Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with symptoms of dysphagia but "normal" esophageal manometry by the Chicago Classification criteria.
Intervention: Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device (Device)
Outcomes
Primary Outcomes
hypopharyngeal intra-bolus
Time Frame: After exerciser regimen, during deglutitive restriction of the larynx
pressure within the swallowed bolus as it passes through the hypopharynx
maximum excursion of the hyo-laryngeal complex
Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx
maximum deglutitive excursion of the hyoid and larynx from the pre-swallow resting position as measured from fluoroscopic images
peak deglutitive pharyngeal peristaltic wave pressure
Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx
Peak deglutitive pharyngeal peristaltic wave pressure will be measured at positions 2-8cm above the upper margin of the manometrically determined upper esophageal sphincter high-pressure zone (UESHPZ)
pharyngeal contractile integral
Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx
Time-space integral of the pharynx during swallows as measured from the manometric display
upper esophageal sphincter (UES) nadir pressure
Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx
minimum pressure during deglutitive UES relaxation
UES anterior-posterior maximum diameter during swallows
Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx
maximum deglutitive diameter in the anterior-posterior direction of the UES measured from fluoroscopic images
peak deglutitive pharyngeal peristaltic wave pressure
Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx
Peak deglutitive pharyngeal peristaltic wave pressure will be measured at positions 2-8cm above the upper margin of the manometrically determined upper esophageal sphincter high-pressure zone (UESHPZ)
hypopharyngeal intra-bolus
Time Frame: Before exerciser regimen, during deglutitive restriction of the larynx
pressure within the swallowed bolus as it passes through the hypopharynx
upper esophageal sphincter (UES) nadir pressure
Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx
minimum pressure during deglutitive UES relaxation
pharyngeal contractile integral
Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx
Time-space integral of the pharynx during swallows as measured from the manometric display
maximum excursion of the hyo-laryngeal complex
Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx
maximum deglutitive excursion of the hyoid and larynx from the pre-swallow resting position as measured from fluoroscopic images
UES anterior-posterior maximum diameter during swallows
Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx
maximum deglutitive diameter in the anterior-posterior direction of the UES measured from fluoroscopic images
Secondary Outcomes
No secondary outcomes reported
Investigators
Reza Shaker, MD
Associate Provost for Clinical and Translational Research, Senior Associate Dean, Director of Clinical and Translational Science Institute, Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology, Principal Investigator
Medical College of Wisconsin