Clinical trial NCT06465355: Effects of an Air Bolus on Primary Peristalsis
Official title: The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Deglutition Disorders
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In healthy adults, determine the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: striated esophageal muscle contractile integral
timeFrame: through study completion, an average of 1 year
measure: smooth esophageal muscle contractile integral
timeFrame: through study completion, an average of 1 year
measure: peristaltic wave velocity
timeFrame: through study completion, an average of 1 year
measure: esophageal clearance time
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: