NCT03986554

Swallowing Pressure Profiles in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine the impact of a pharyngeal High Resolution Manometry catheter on swallowing biomechanics

Detailed description

During pharyngeal High Resolution Manometry (pHRM) a small bore flexible catheter is introduced into the pharynx to detect intrabolus pressure and contact of pharyngeal structures during swallowing. The presence of the catheter through the upper esophageal sphincter (UES) leads to a violation of its natural closed state. It is not clear how this intrusion influences the swallowing biomechanics . Hence, this project's goal is to identify how hyoid movement is altered during swallowing with the presence of a pHRM catheter in place.

Conditions

• Healthy

Interventions

Type	Name	Description
PROCEDURE	Videofluoroscopic swallow study	The Swallowing Systems Core laboratory is fully equipped to perform VFSS with a C-arm (OEC 9900) that is dedicated solely for research purposes. VFSS recordings will be kept to a minimum and only turned on during the execution of each swallow in all sequences. Video recording and images captured during the VFSS will be synced and saved to a secure server for data analysis. VFSS allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks. The physiological swallowing measures (temporal and kinematic movement of the hyolaryngeal complex during swallowing) cannot be visualized with any other technique. Patients will swallow only water. Aspiration (bolus into trachea) is not expected to occur during this study given that the individuals recruited will have no prior history of disease or disorder, and aspiration is uncommon in healthy individuals.
PROCEDURE	pharyngeal High Resolution Manometry	This procedure will only take place once during sequence 2 of the randomization B session. If desired, a small amount (\< 0.5 mL) of topical 2% viscous lidocaine hydrochloride will be applied to the participant's nostril of choice prior to catheter insertion. The catheter will be placed through the nasal passage, oropharynx, and hypopharynx to the esophagus. Correct catheter placement will be verified with VFSS. With the catheter in place, the subject will perform 10 swallows of 10ml and is expected to take approximately 2.5 minutes. The catheter will then be removed and the subject will move on to sequence 3. Individuals have the option to decline this procedure if it is uncomfortable or difficult to tolerate.

Timeline

• Start date: 2019-07-09
• Primary completion: 2019-07-19
• Completion: 2019-07-19
• First posted: 2019-06-14
• Last updated: 2020-03-17

Locations

1 site across 1 country: United States