Effects of an Air Bolus on Primary Peristalsis

Deglutition Disorders Clinical Trial

Official title:

The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465355
• Other study ID #: PRO00035855
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: March 19, 2025

Study information

• Verified date: June 2024
• Source: Medical College of Wisconsin
• Contact: Reza Shaker, MD
• Phone: 4149556840
• Email: rshaker[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 19, 2025
• Est. primary completion date: March 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	esophageal clearance time	time for the entire swallowed bolus to travers the esophagus in seconds	through study completion, an average of 1 year