Effects of an Air Bolus on Primary Peristalsis

Medical College of Wisconsin

Status: Withdrawn

Conditions: Deglutition Disorders

Treatments: Procedure: pharyngo-esophageal high-resolution manometry

Study type: Interventional

Funder types: Other

Identifiers

NCT06465355

PRO00035855

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 21 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Healthy adults

Other group

Description:

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).

Treatment:

Procedure: pharyngo-esophageal high-resolution manometry