Deglutition Disorders
Conditions
Brief summary
Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
Detailed description
Study Procedures and Analyses 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. After 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 pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure. 3. Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows. 4. Following completion of the study, the manometry catheter and the single lumen tube will be removed. 5. The participant will also be instructed to resume their regular diet and activity. 6. All the pressure recordings will be analyzed by two individuals in a blinded fashion. The investigators will compare motility pressure metrics like striated esophageal muscle contractile integral, esophageal smooth muscle contractile integral, peristaltic wave velocity and esophageal clearance time to evaluate the potential differences in esophageal motility metrics when an air bolus is allowed to flow into the esophagus compared to those metrics when air is shunted out of the pharynx by a trans-nasal tube vented to the atmosphere. Statistical analysis will be performed in a repeated measures technique comparing metrics with and without the pharyngeal shunt stopcock closed.
Interventions
PROCEDUREpharyngo-esophageal high-resolution manometry
The high resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure. 3. Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows.
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
In healthy adults, determine the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders * Age 21 to 90 years
Exclusion criteria
* Under the age of 21 * Over the age of 90 * Presence of pharyngo-esophageal disease or motility disorders * Pregnancy * Lidocaine allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| striated esophageal muscle contractile integral | through study completion, an average of 1 year | Motility pressure metric to measure contractile vigor of the proximal esophagus in mmHg-cm-seconds |
| peristaltic wave velocity | through study completion, an average of 1 year | average speed at which the primary peristaltic pressure wave traverses the esophagus in cm/second |
| smooth esophageal muscle contractile integral | through study completion, an average of 1 year | Motility pressure metric to measure contractile vigor of the distal esophagus in mmHg-cm-seconds |
| esophageal clearance time | through study completion, an average of 1 year | time for the entire swallowed bolus to travers the esophagus in seconds |
Countries
United States
Outcome results
None listed