NCT06465355

Effects of an Air Bolus on Primary Peristalsis

The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Deglutition Disorders

Interventions

Type	Name	Description
PROCEDURE	pharyngo-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.

Timeline

• Start date: 2019-10-10
• Primary completion: 2024-12-17
• Completion: 2024-12-17
• First posted: 2024-06-18
• Last updated: 2025-04-28

Locations

1 site across 1 country: United States