High Resolution Manometry for Swallowing (HRM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01773330
First received: January 11, 2013
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.


Condition Intervention Phase
Motility Disorder
Procedure: esophageal manometry
Dietary Supplement: Gatorade
Other: Supine position
Other: Semi-recumbent position
Procedure: Sitting
Procedure: Standing
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: High Resolution Manometry: Optimizing the Swallow Protocol

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits. [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.


Secondary Outcome Measures:
  • Normal HRM values for a 200 ml provocative swallow. [ Time Frame: up to 5 minutes ] [ Designated as safety issue: No ]
    The patient is instructed to swallow 200 ml of Gatorade in the sitting position.

  • Bolus clearance for each swallow with impedance. [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.

  • Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance. [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.

  • Standardization of the testing protocol for HRM and the reliability of volume and number of swallows. [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.


Estimated Enrollment: 90
Study Start Date: October 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
Procedure: esophageal manometry
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed.There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
Dietary Supplement: Gatorade
The patient will be given Gatorade to drink at various times during the study.
Other: Supine position
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
Other Names:
  • Semi-recumbent
  • Sitting
  • Standing up
Other: Semi-recumbent position
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
Other Names:
  • Supine position
  • Sitting position
  • Standing up
Procedure: Sitting
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
Other Names:
  • Supine
  • Semi-recumbent
  • Standing
Procedure: Standing
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
Other Names:
  • Supine position
  • Semi-recumbent position
  • Sitting position

Detailed Description:

The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-80
  • Healthy Volunteer
  • No clinical evidence of dysphagia

Exclusion Criteria:

  • History of prior dysphagia
  • Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus)
  • Known gastrointestinal malignancy
  • Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers)
  • Previous esophageal or gastric surgery
  • Significant cardiac or respiratory disease
  • Pregnancy (a pregnancy test will be performed in women of child-bearing potential)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773330

Contacts
Contact: Qing Zhang, M.D., Ph.D. 352-273-9477 qing.zhang@medicine.ufl.edu

Locations
United States, Florida
Shands Endoscopy Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Qing Zhang, M.D., Ph.D.         
Contact: Hui Li, M.B    3522650680 ext 43448    Hui.Li@medicine.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Qing Zhang, M.D., Ph.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01773330     History of Changes
Other Study ID Numbers: 502-2012
Study First Received: January 11, 2013
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
high resolution manometry
provocative swallow
impedence

ClinicalTrials.gov processed this record on July 26, 2014