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出境医 / 临床实验 / Swallowing Pressure Profiles in Healthy Adults

Swallowing Pressure Profiles in Healthy Adults

Study Description
Brief Summary:
This study is designed to determine the impact of a pharyngeal High Resolution Manometry catheter on swallowing biomechanics

Condition or disease Intervention/treatment Phase
Healthy Procedure: Videofluoroscopic swallow study Procedure: pharyngeal High Resolution Manometry Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will include healthy adults, between the ages of 18 and 45 years with no major medical history.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Swallowing Pressure Profiles in Healthy Adults
Actual Study Start Date : July 9, 2019
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019
Arms and Interventions
Arm Intervention/treatment
Randomization Visit A
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.
 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.
Other Name: VFSS, x-ray of swallowing
Randomization Visit B
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.
 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.
Other Name: VFSS, x-ray of swallowing

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.
Other Name: pHRM, HRM
Outcome Measures
Primary Outcome Measures :
  1. Change in peak anterior and superior hyoid movement [ Time Frame: Baseline; Week 1 ]
    peak hyoid movement (mm)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Florida
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Emily K Plowman, PhD University of Florida
Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE July 9, 2019
Actual Primary Completion Date July 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2020) 		Change in peak anterior and superior hyoid movement [ Time Frame: Baseline; Week 1 ]
peak hyoid movement (mm)
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Changes in primary temporal kinematic variables associated with hyolaryngeal elevation events. [ Time Frame: Baseline; Week 1 ]
    Duration of laryngeal vestibule closure (dLVC), duration to laryngeal vestibule closure (dtLVC), and duration to maximum hyoid bone elevation (dtHME) will be measured.
  • Changes in kinematic variables associated with hyolaryngeal elevation events. [ Time Frame: Baseline; Week 1 ]
    The anterior and superior displacement of the hyoid and the larynx will be measured at rest and during swallowing.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Swallowing Pressure Profiles in Healthy Adults
Official Title  ICMJE Swallowing Pressure Profiles in Healthy Adults
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Participants will include healthy adults, between the ages of 18 and 45 years with no major medical history.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
    Other Name: VFSS, x-ray of swallowing
  • 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.
    Other Name: pHRM, HRM
Study Arms  ICMJE
  • Randomization Visit A
    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.
    Intervention: Procedure: Videofluoroscopic swallow study
  • Randomization Visit B
    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.
    Interventions:
    • Procedure: Videofluoroscopic swallow study
    • Procedure: pharyngeal High Resolution Manometry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2019) 		10
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2019) 		12
Actual Study Completion Date  ICMJE July 19, 2019
Actual Primary Completion Date July 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986554
Other Study ID Numbers  ICMJE IRB201901651
OCR24403 ( Other Identifier: UF OnCore )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily K Plowman, PhD University of Florida
PRS Account University of Florida
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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