Swallowing Pressure Profiles in Healthy Adults

University of Florida

Status: Completed

Conditions: Healthy

Treatments: Procedure: pharyngeal High Resolution Manometry; Procedure: Videofluoroscopic swallow study

Study type: Interventional

Funder types: Other

Identifiers

NCT03986554

OCR24403 (Other Identifier)

IRB201901651

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adults between the ages of 18-45 with no major medical conditions.
• no specific gender or race will be excluded or targeted for participation in this study.

Exclusion criteria

• adults who are pregnant
• adults with swallowing impairment, brain injury, deviated septum, G.I. strictures, obstructions, or Zenker's diverticulum, surgeries to nose, neck, or throat, or bleeding disorders will be excluded from this study

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Randomization Visit A

Other group

Description:

Participants enrolled in this arm will consume 300ml of water over 60 minutes. Each session will consist of 30 swallows broken into three 10-swallow sequences of 10ml of water. Each sequence will be use VFSS to visualize swallows.

Treatment:

Procedure: Videofluoroscopic swallow study

Randomization Visit B

Other group

Description:

Participants enrolled in this arm will consume 300ml of water over 60 minutes. Each session will consist of 30 swallows broken into three 10-swallow sequences of 10ml of water. Sequences 1 and 3 will use videofluoroscopy only, while sequence 2 will use VFSS with simultaneous pharyngeal high resolution manometry in order to visualize swallows.

Treatment:

Procedure: Videofluoroscopic swallow study

Procedure: pharyngeal High Resolution Manometry