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Swallowing Pressure Profiles in Healthy Adults

NCT03986554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-03-17

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Emily K Plowman, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2019-07-19
Completion
2019-07-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986554 on ClinicalTrials.gov