Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465355
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-10
Brief Title:
Effects of an Air Bolus on Primary Peristalsis
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 158 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
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 158 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None