Effects of an Air Bolus on Primary Peristalsis

NCT06465355 | Withdrawn

• 1 other identifier: PRO00035855
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (4)

• striated esophageal muscle contractile integral

  Motility pressure metric to measure contractile vigor of the proximal esophagus in mmHg-cm-seconds

  through study completion, an average of 1 year

• smooth esophageal muscle contractile integral

  Motility pressure metric to measure contractile vigor of the distal esophagus in mmHg-cm-seconds

  through study completion, an average of 1 year

• peristaltic wave velocity

  average speed at which the primary peristaltic pressure wave traverses the esophagus in cm/second

  through study completion, an average of 1 year

• esophageal clearance time

  time for the entire swallowed bolus to travers the esophagus in seconds

  through study completion, an average of 1 year

Study Arms (1)

Healthy adults

OTHER

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).

Procedure: pharyngo-esophageal high-resolution manometry

Interventions

pharyngo-esophageal high-resolution manometry PROCEDURE

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.

Healthy adults

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders
• Age 21 to 90 years

You may not qualify if:

• Under the age of 21
• Over the age of 90
• Presence of pharyngo-esophageal disease or motility disorders
• Pregnancy
• Lidocaine allergy

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Provost for Clinical and Translational Research, Senior Associate Dean and Director of the Clinical and Translational Science Institute of SE WI, and the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology

Model Details: In healthy adults, determine the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: October 10, 2019
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: April 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)