Effects of an Air Bolus on Primary Peristalsis
- Conditions
- Deglutition Disorders
- Interventions
- Procedure: pharyngo-esophageal high-resolution manometry
- Registration Number
- NCT06465355
- Lead Sponsor
- Medical College of Wisconsin
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 40
- Male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders
- Age 21 to 90 years
- Under the age of 21
- Over the age of 90
- Presence of pharyngo-esophageal disease or motility disorders
- Pregnancy
- Lidocaine allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy adults pharyngo-esophageal high-resolution manometry Pharyngo-esophageal high resolution manometry with affixed single-lumen, end-hole catheter wherein one end of the single lumen catheter is in the pharynx and the other is connected to an external stopcock to vent or not vent the pharynx to atmosphere during twenty dry swallows (10 vented, 10 unvented).
- Primary Outcome Measures
Name Time Method 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
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
esophageal clearance time through study completion, an average of 1 year time for the entire swallowed bolus to travers the esophagus in seconds
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States