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| ID | Type | Description | Link |
|---|---|---|---|
| OCR24403 | Other Identifier | UF OnCore |
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This study is designed to determine the impact of a pharyngeal High Resolution Manometry catheter on swallowing biomechanics
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomization Visit A | Other | 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. |
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| Randomization Visit B | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videofluoroscopic swallow study | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak anterior and superior hyoid movement | peak hyoid movement (mm) | Baseline; Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K Plowman, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Gainesville | Florida | 32610 | United States |
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Participants will include healthy adults, between the ages of 18 and 45 years with no major medical history.
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| pharyngeal High Resolution Manometry | Procedure | 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. |
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